Ablation

Researchers are studying a new minimally invasive treatment for breast cancer patients who cannot undergo surgery because of medical reasons or personal choice. This study evaluates a combined cryo-thermal ablation system, a device developed in China that uses both extreme cold and heat to destroy tumor tissue. The goal is to assess the safety and effectiveness of this treatment in patients with early breast cancer who are unsuitable for surgical removal of tumors. The treatment uses a special device that applies deep freezing with liquid nitrogen and high-intensity heating with anhydrous ethanol. This combined approach aims to destroy the breast tumor while reducing complications such as bleeding or tumor spread along the needle path. Patients receive ultrasound-guided ablation of the breast tumor, and the device’s effects are closely monitored during and after treatment. The study follows patients prospectively using a breast disease cohort database, with different groups including those who cannot have surgery due to age or health, those with advanced or metastatic disease, and those refusing surgery. Participants will undergo data collection including imaging tests like ultrasound, mammography, and MRI, plus laboratory and pathology assessments before and after ablation. Follow-up occurs every six months for at least five years, tracking outcomes such as tumor recurrence, disease-free survival, and overall survival. Safety is monitored through reporting of complications within three months after treatment. The primary focus is on local tumor control and complication rates, with additional analysis of immune response and imaging features related to recurrence risk.

Researchers are evaluating microwave ablation (MWA) as a minimally invasive treatment option for patients with relapsed Graves' disease who have previously been treated with anti-thyroid drugs but experienced a return of symptoms. Graves' disease is the most common cause of hyperthyroidism, and conventional treatments include anti-thyroid drugs, radioiodine, and surgery. However, these treatments have drawbacks such as side effects, risk of worsening eye symptoms, or surgical complications, which has led to interest in alternative therapies like MWA. In this study, all participants will receive ultrasound-guided MWA treatment using a device that inserts a microwave antenna into the thyroid gland to apply thermal energy and ablate the tissue. The procedure targets the entire thyroid gland, including both lobes, the isthmus, and the pyramidal lobe. This approach avoids surgical scars and preserves the organ, and it is performed as an outpatient procedure. The study does not involve comparison groups but focuses on evaluating this treatment. During the study, participants will be monitored for remission of Graves' disease six months after the procedure. Researchers will also measure changes in quality of life and thyroid gland volume at six months. The study includes follow-up assessments to evaluate treatment outcomes and safety. Participants can expect clinical evaluations and ultrasound examinations as part of their involvement. The total participation duration extends at least six months post-treatment.

Researchers are studying patients with papillary thyroid carcinoma (PTC) who have undergone thermal ablation at a hospital since February 2023. The study aims to analyze factors that may influence the recurrence of PTC after this treatment. Data collected include demographic information, ultrasound results, laboratory tests, and thyroid disease-related scales measuring fatigue, depression, and stress. The study involves no additional interventions beyond the thermal ablation already received by participants. Ultrasound and pathology are used to confirm diagnosis and characteristics of the thyroid nodules before treatment. Follow-up occurs for one to five years to observe the recurrence of PTC. Participants provide demographic and medical data before and after ablation. Researchers monitor recurrence using ultrasound and assess thyroid-related symptoms through questionnaires. The primary outcome measured is the rate of PTC recurrence over one to five years. The study is observational, with no experimental treatment assigned, and participants are monitored over time to better understand recurrence risks.

Researchers are evaluating the use of a hybrid cryo-thermal ablation system compared to traditional breast-conserving surgery for women diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer. This prospective, randomized controlled trial aims to assess differences in tumor recurrence, treatment safety, and patient quality of life after these treatments. The study involves patients newly diagnosed and treated at a single center in China using an advanced minimally invasive device combining freezing and heating for tumor destruction. Participants will be randomly assigned to receive either the hybrid cryo-thermal ablation or standard breast-conserving surgery. The ablation procedure includes ultrasound-guided insertion of a probe into the tumor, followed by cycles of freezing and heating to destroy the tumor tissue. The surgery group undergoes breast-conserving surgery following Chinese clinical guidelines to remove the tumor with negative margins. Both treatments intend to fully cover the tumor area, ensuring oncological safety. During the trial, participants will be monitored for surgical details, complications, immune cell changes, and treatment efficacy including local recurrence rates and survival outcomes over several years. Aesthetic results and quality of life will also be evaluated using patient surveys. Imaging and pathological analyses will explore tumor response and potential links between imaging features and recurrence risk. The study includes follow-up assessments and safety evaluations up to five years after treatment to understand long-term outcomes.

Researchers are investigating the mechanisms that sustain persistent atrial fibrillation (AF) and ventricular fibrillation (VF) in humans. This study focuses on understanding how specific areas of high-frequency electrical activity, called DFASI domains, maintain these heart rhythm disorders. The project aims to explore how targeting these domains with ablation therapy affects AF dynamics and clinical outcomes, and to extend these findings to improve treatment options for patients with recurrent VF. The study involves two groups: a control group receiving circumferential pulmonary vein isolation (CPVI) alone, and an active group receiving CPVI plus additional ablation targeting DFASI domains identified through non-invasive mapping. After CPVI in both groups, researchers will perform non-invasive mapping to assess fibrillation patterns, with the active group undergoing sequential ablation of the DFASI domains. Adenosine will be used to evaluate changes in fibrillation dynamics before and after ablation. Participants will undergo detailed non-invasive mapping during the procedure to identify reentrant areas with high activation frequency. Researchers will measure changes in fibrillation dynamics during and after ablation, and track arrhythmia burden over follow-up visits at 3, 6, and 12 months. The study includes safety monitoring and aims to improve understanding of fibrillation physiology and treatment effectiveness over time.

Researchers are investigating the use of ablation combined with lenvatinib and a PD-1 inhibitor for advanced hepatocellular carcinoma (HCC) with oligometastasis. This study explores a subtype of metastatic HCC where there are limited metastases, aiming to evaluate whether removing these metastases can improve survival. The trial is a multicenter, prospective, phase II study focused on the safety and effectiveness of this combined approach. Participants receive a treatment combining ablation of oligometastases using microwave ablation, radiofrequency ablation, or cryoablation, along with systemic therapy using lenvatinib and PD-1 inhibitors. Ablation targets metastases limited to five sites in no more than two organs, each measuring up to 5 cm. Patients must have already received at least 3 months of lenvatinib and PD-1 inhibitor therapy with controlled intrahepatic tumors before ablation. Throughout the study, participants will be monitored for progression-free survival over 24 months as the primary outcome. Additional assessments include overall survival, objective response rate, and adverse events within 12 to 24 months. Researchers will perform regular evaluations to track treatment response and safety, with the total study duration extending to August 2027.

Researchers are investigating the use of ablation combined with systemic therapy for treating advanced hepatocellular carcinoma (HCC) with pulmonary oligometastases. Pulmonary oligometastases represent a stage between localized and widespread disease. While ablation has been effective for intrathoracic metastases from various cancers, its role specifically in HCC with lung oligometastases is still being evaluated. This multicenter retrospective study aims to provide clinical evidence on this treatment approach compared to systemic therapy alone. Participants receive either ablation of pulmonary metastases using image-guided techniques such as microwave ablation, radiofrequency ablation, or cryoablation under CT guidance combined with systemic therapy, or systemic therapy alone following treatment instructions. Ablation targets complete destruction of lung metastases. All participants have already received first-line systemic therapy and may have undergone locoregional treatments like transarterial chemoembolization or hepatic arterial infusion chemotherapy. During the study, researchers will monitor participants for progression-free survival over 12 months as the primary outcome. Secondary outcomes include overall survival at 24 months and objective response rate at 12 months. Participants will be followed with clinical assessments to evaluate tumor control and treatment effects. The study includes adults aged 18 to 80 years with controlled intrahepatic tumors and limited metastatic sites, aiming to understand the benefits and risks of adding ablation to standard systemic therapy in this population.

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation (PVI) using high power short duration (HPSD) radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation (AF). This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedure's overall safety and efficacy.

Atrial fibrillation (AF) is a common heart rhythm disorder that greatly increases the risk of stroke, heart failure, hospitalization, and death. This research aims to compare two treatment approaches for elderly AF patients who are frail and have a high risk of bleeding. The study evaluates catheter ablation combined with left atrial appendage occlusion (LAAO) against catheter ablation combined with long-term oral anticoagulation (OAC), addressing a current gap in evidence about the best strategy for this vulnerable group. Participants will be randomly assigned to one of two groups: one receiving catheter ablation plus LAAO, a device-based procedure to prevent stroke, and the other receiving catheter ablation plus standard oral anticoagulation therapy. The LAAO procedure may be done during the ablation session or separately. After LAAO, participants receive anticoagulation for 90 days, followed by possible de-escalation based on imaging results. The other group continues guideline-directed anticoagulation after ablation. Both groups are closely monitored for safety and effectiveness. During the 24-month study, participants will undergo regular assessments including ECGs, Holter monitoring to track heart rhythm, and imaging tests to evaluate heart function and device status. Researchers will measure outcomes such as stroke, bleeding events, death, AF recurrence, and quality of life. Additional evaluations include frailty scores, cognitive function, and daily living activities. The study also monitors procedural success, hospital stay length, and complications to help determine which treatment better supports elderly patients with AF.

This research aims to evaluate the immediate effectiveness and durability of the cavo-tricuspid isthmus (CTI) block using pulsed electric field (PEF) energy in patients with atrial fibrillation (AF) and typical atrial flutter. The study will also determine the best waiting time to detect recovery of conduction after PEF CTI ablation and assess the usefulness of routine adenosine testing for dormant conduction. Additionally, it compares two catheter configurations, basket and flower, to study differences in acute success and side effects like hemolysis and coronary vasospasm. Participants undergo catheter ablation of the CTI using either the flower or basket configuration of the Farapulse catheter in a randomized 1:1 assignment. Ablations are performed during atrial pacing under anesthesia with intracardiac echocardiography guidance. Patients receive sublingual nitrates before ablation, and sequential PEF applications are delivered until CTI block is achieved. Adenosine testing for dormant conduction and monitoring of conduction recovery times are performed during the procedure. Blood samples to measure plasma biomarkers are collected before and after CTI isolation. Throughout the study, patients are monitored using catheters in the heart, electrocardiograms, and intracardiac imaging. Researchers measure the acute durability of the CTI block, time to conduction recovery, presence of dormant conduction via adenosine testing, plasma hemoglobin levels, and coronary vasospasm occurrence. The study includes 150 patients aged 18 and older, with follow-up during the ablation procedure to assess these outcomes under continuous observation. The total participation time corresponds to the duration of the ablation procedure and associated assessments.