Ablation

The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation. Researches will break the method of this investigation into two steps: First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site. The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group.

1\. Study Design 1. Prospective Cohort Study Study Subjects and Selection Criteria 2. This study is based on the breast disease cohort database of Peking University People's Hospital Breast Center. Patients with pathologically confirmed breast cancer who refused, were intolerant of, or unsuitable for surgical treatment and received combined cryoablation and thermal ablation were prospectively enrolled. The specific inclusion and exclusion criteria are as follows: 1. Inclusion Criteria (all conditions must be met): ≥18 years old; Breast cancer confirmed by core needle biopsy; Tumor lesions clearly visible on ultrasound; No contraindications for cryoablation such as coagulation disorders; Presence of reasons unsuitable for conventional surgical resection: Patients intolerant to general anesthesia or surgical treatment due to medical conditions; Due to unresectable and/or metastatic disease; Patient refusal of surgery, etc.; Agree to undergo ablation surgery and sign the informed consent form. 2. Exclusion Criteria (Participants will be excluded if any of the following apply): Missing clinical and pathological data (such as imaging or pathological materials); Pregnant or lactating women; Known allergies, intolerance, or contraindications to cryotherapy (such as cryoglobulinemia, presence of implanted electronic devices); Vulnerable populations, including those with neurological disorders, cognitive impairments, critically ill patients, etc. 3)Grouping of Study Subjects This study is a prospective cohort study. The decision to undergo combined cold and heat ablation therapy was made through mutual consultation between patients and attending physicians, while the remaining systemic treatments were not affected by the study.Cohort 1: Ablation therapy for patients who cannot tolerate standard surgery due to advanced age or comorbidities;Cohort 2: Ablation therapy for patients with unresectable/metastatic diseases who are not suitable for surgical resection;Cohort 3: Ablation therapy chosen by patients who refuse surgical treatment for personal reasons. 4)Research Steps Screen patients who meet the inclusion criteria and exclude those who meet the exclusion criteria. Collect patients' clinicopathological data: age, menstrual status, accompanying diseases; tumor imaging information, including ultrasound, mammography, MRI reports, tumor size, and axillary lymph node status; pathological information, including pathological type, histological grade, hormone receptor status, and postoperative adjuvant treatment plans. Breast primary tumors receive standard combined cryoablation and thermal ablation treatment, and collect imaging and histological laboratory data during and after treatment. Retrieve patients' prognosis information from the follow-up database, including recurrence, metastasis, second primary tumor, and mortality events. 5)Follow-up Plan and Contents: Postoperative Complications (within 3 months): Skin damage Poor incision healing Infection Seroma formation Nipple or flap ischemia/necrosis Survival-related Follow-up: Recurrence Metastasis Second primary tumor Mortality events Follow-up Methods: Telephone WeChat client of Peking University People's Hospital Follow-up System Follow-up Interval: 6 months Follow-up Duration: More than 5 years 6)Selection and Confirmation of Primary Measurement Indicators or Outcome Measures Primary Study Endpoint - Safety: Intraoperative complications (e.g., bleeding, vascular/nerve injury) Postoperative complications (infection, hematoma, frostbite, breast deformity, paresthesia, etc.), recorded according to CTCAE v5.0 classification Local tumor recurrence rate (Ipsilateral Breast Cancer Recurrence, IBTR): defined as the time from surgery to ipsilateral breast tumor recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event Secondary Study Endpoints: Disease-free survival (DFS): time from study enrollment to the first occurrence of failure events, including ipsilateral local-regional recurrence, contralateral breast cancer, distant recurrence, or death from any cause Overall survival (OS): time from study enrollment to death from any cause Exploratory analysis: using specimen bank preserved samples and imaging data to analyze post-ablation tumor tissue pathological response, blood immune function assessment, and the correlation between postoperative imaging (MRI/ultrasound) characteristics and recurrence risk All data collection is sourced from the established Peking University People's Hospital Breast Disease Cohort Database (PKUPH Breast Disease Cohort). 7)The primary study outcome was a local IBTR at 5 years through the width of the 95% confidence interval (CI). A sample size was calculated for this outcome. For a two-sided 95% exact Clopper Pearson confidence interval of the IBTR rate whose true value was 5%, a sample size of 200 patients was required to yield a half-width of 5% at most with more than 99% power. In this context, power is the probability (conditional method) of obtaining a confidence interval a half-width less than or equal to the hypothesized value.

Graves' disease is the most common cause of hyperthyroidism, with conventional treatment options being anti-thyroid drugs (ATD), radioiodine (RAI) and surgery. For ATD, it has been the first-line treatment over decades. Despite its ability to induce remission, minor side effects such as skin rash, gastrointestinal disturbance and arthralgia occur in around 5% of patients, while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening. Patients are usually treated with ATD for 12 to 18 months but the relapse rate was reported to be up to 50-60% which these patients would require more definitive treatment options with RAI or thyroidectomy. However, RAI is not preferable in patients with Graves' ophthalmopathy as it could further worsen eye symptoms. RAI may also cause hypothyroidism in a substantial proportion of patients, with a subsequent need for lifelong thyroxine replacement. As for thyroidectomy, it carries an overall 2-10% risk of complications including bleeding, transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism. Due to the drawbacks of the various conventional treatment options, there has been increasing interest in the development of minimally invasive treatment alternatives in recent years. With the evolution of thermal ablative strategies, high-intensity focused ultrasound (HIFU) and radiofrequency ablation (RFA) have been reported as feasible treatment options for relapsed Graves' disease. There has also been increasing reports in the use of microwave ablation (MWA) in the treatment of benign thyroid nodules. MWA works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound (USG) guidance. The active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect. As compared to RFA, MWA is not affected by heat sink effect and may require a shorter treatment time. Similar to other thermal ablative approaches, MWA has the merits of avoiding surgical scar, organ preservation as well as being an ambulatory procedure.

A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal ablation in our hospital since February 2023 was established as the study object. Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory tests, and thyroid disease-related scales such as fatigue, depression, and stress were collected. The influencing factors of PTC recurrence were analyzed.

The present research project proposes to characterize the physiology of persistent human AF after therapeutic interaction (ablation) with the "DFASI domains", exploring its impact on the dynamics and maintenance of AF in patients. The investigators propose to reveal the physiological mechanisms by which this interaction improves the clinical outcomes of our patients (Objective 1), which will allow the development of more efficient ablation strategies (Objective 2). Likewise, preclinical models developed by our group in collaboration with the National Center for Cardiovascular Research support the translation of our technological developments to the field of human VF. Therefore, in the present research project the investigators propose to explore the physiological significance of "DFSI domains" in patients with recurrent VF and the eventual development of efficient ablative therapies (Objective 3). With the proposed objectives, the project addresses the challenges posed in the diagnosis and treatment of cardiovascular diseases within the National Health System, in the context of a prevalent pathology (cardiac fibrillation) with high morbidity and mortality.

Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with metastases-directed ablation in advanced HCC. This study focuses on the management of ablation of oligometastasis therapy combined with lenvatinib and PD-1 inhibitor. This study aims to evaluate the survival benefits of ablating oligometastasis for advanced HCC.

Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. This multicenter study focuses on the management of ablation of oligometastasis therapy combined with systemic therapy.

Patients will be screened in ambulatory and scheduled for AF ablation according to current guidelines. Ablation will be usually performed under effective oral anticoagulation. Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could be executed as a reference for volume estimations obtained with the mapping system. Ablation will be carried out under mild or deep sedation, or general anesthesia according to center preference. At least 2 femoral vein access will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be achieved using a standard approach. Then, the mapping catheter (LASSO, Penta-ray, Octa-ray catheter) and the ablation catheter (QDot Micro catheter) will be placed in the left atrium. Heparin will be administered before the transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial fibrillation at the beginning of the index procedure will undergo electrical cardioversion. After left atrium reconstruction the effective PV-left atrium electrical connection will be checked with the mapping catheter. In all patients a wide antrum circumferential ablation aimed at PV isolation will be performed using the QDot Micro catheter in QMode+ mode (90 w for 4 sec) for the whole ablation or in an hybrid mode (QMode + for posterior wall and QMode guided by AI in the anterior wall), according to the operator preference. The maximum interlesion distance will be \<6 mm (16,17). According to operator preference it will be performed an ablation line encircling each PV or two ablation lines encircling the right and the left PVs. At the end of the ablation effective PV isolation (entry and exit block), will be checked with mapping catheter. After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will be directed to the gaps identified by the mapping catheter. All patients will undergo a post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other acute complications. After ablation, patients will undertake regular follow-up assessments (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms related to the previous arrhythmia during a supplementary detailed follow up (6-12 months subsequent to catheter ablation) will be considered free of arrhythmia recurrence

Background Cavo-tricuspid isthmus (CTI) ablation is commonly performed as a concomitant procedure in patients undergoing pulmonary vein isolation (PVI) or more extensive left atrial ablations for the treatment of atrial fibrillation (AF). While the acute and long-term resumption of conduction in the CTI after radiofrequency ablation has already been investigated, the acute durability of the CTI block created by pulsed-electric field (PEF) energy has not been systematically evaluated. Study population A prospective, multicentric randomized study conducted at high-volume centre with the routine use of intracardiac echocardiography (ICE). A total of 150 consecutive patients with paroxysmal AF undergoing PVI by PEF energy with documented typical atrial flutter or patients with persistent AF in whom catheter ablation of CTI is planned as a part of a complex procedure will be enrolled in the study. Methods Procedures will be performed under general anaesthesia (GA) or deep analgo-sedation and on uninterrupted anticoagulation. One decapolar catheter will be introduced into the coronary sinus (CS). A duodecapolar catheter will be placed in the right atrium around the tricuspid annulus. A single transseptal puncture will be performed under ICE guidance. After obtaining the left atrial (LA) access, the Faradrive sheath will be redrawn into the right atrium. Patient presenting with AF or other atrial arrhythmias at the beginning of the procedure will be cardioverted. Prior to initiating pulsed field ablation (PFA) on the CTI, sublingual nitrates will be administered in the form of two sprays of nitroglycerin at a dose of 0.30 mg per spray. The CTI ablation will be performed during regular atrial pacing from the proximal CS at a cycle length of 600 ms. Sequential applications of PEF energy will be delivered in an overlapping fashion from the tricuspid annulus to the inferior cava vein under ICE guidance. Patients will be randomized in a 1:1 ratio based on the configuration of the catheter used to achieve CTI block (basket vs. flower). In both groups, three applications will be deployed at each spot. If acute block is not achievable using the randomized configuration, patients will be ablated using the other configuration and any additional lesions per operator discretion to achieve acute block. After demonstrating the bidirectional CTI block with standard pacing maneuvers (differential pacing from duodecapolar catheter and proximal CS), the surface electrocardiogram (ECG) will be analyzed across all 12 leads to evaluate for the presence of ST segment elevation. The left atrial procedure will be then performed during regular atrial pacing from the proximal CS. An eventual conduction recovery over the CTI and the corresponding time since the last ablation on the CTI will be recorded. Dormant conduction over the CTI will be assessed using an I.V. bolus of 12-18 mg of adenosine during continuous atrial pacing immediately after the confirmation of the CTI block and at the end of the procedure. The total waiting time and number of PEF applications on the CTI will be documented. At the end of the procedure, additional PEF applications per operator discretion on the CTI will be delivered if needed. Sample size While no clear data on comparison of different Farapulse configurations on CTI are available, with 150 patients in the trial at a given expected acute success rate of 85 % in basket configuration given our clinical experience and a noninferiority design, a noninferiority margin of 15% at a power level of 82% can be tested. Plasmatic biomarkers Venous blood samples for the assessment of plasma biomarkers (free hemoglobin \[fHb\], lactate dehydrogenase \[LDH\], total bilirubin, and haptoglobin) will be collected at two time points: before the procedure (T1) and after CTI isolation before LA ablation (T2). Clinical implications 1. Achieving CTI block at the beginning of the catheter ablation of AF may provide sufficient waiting time to verify the durability of the block on TCI and thus enhance the long-term clinical effect of the procedure. 2. An absence of adenosine-induced CTI reconnection immediately after the CTI block could predict the durability of block at the end of the procedure and obviate the need for prolonged waiting period. 3. The use of the flower configuration to achieve CTI block could be associated with a non-inferior acute success rate and lower incidence of hemolysis.

Cryoballoon ablation is a relatively new ablation technique for the treatment of dysplastic Barrett's esophagus (BE). Previous studies with this technique have shown that treatment is safe and effective. When compared to other ablation techniques, cryoballon ablation has several potential advantages, including less pain and less complications such as stricture formation after treatment. Recently, a cryoballoon ablation system has become available which enables treatment of larger esophageal surfaces. Although a recent clinical study with this new device has shown promising results, the lowest possible dose that optimally balances safety and efficacy is still unknown. This study is a multicenter, prospective, intervention study consisting of two phases: the treatment phase and the follow-up phase. During the treatment phase, patients will undergo an upper endoscopy during which CBAS180 treatment will be performed. Treatment consists of two CBAS180 applications, starting just below the gastroesophageal junction (GEJ), resulting in a circumferential ablation of 3cm in length. During the treatment phase, two doses will be tested consecutively starting with the lowest dose (i.e. 1.2mm/sec). For each dose a total of 25 patients will be included. An interim analysis will be performed after treatment of the first 25 patients with the lowest dose of 1.2mm/sec, before proceeding to treatment of the additional 25 patients with a higher dose of 1.1mm/sec. The follow-up phase starts after CBAS180 treatment and ends after first follow-up endoscopy at 10 weeks (±2 weeks) after treatment. Therefore, the study duration will be approximately 3 months for each individual patient. The investigators expect to report the primary outcome for all participating patients within 2 years.