Mercogliano

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation using high power short duration radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation. This prospective, multi-center study aims to understand how clinical and procedural factors relate to the recurrence of atrial fibrillation 12 months after ablation. At least 850 patients will be enrolled to provide reliable data on treatment outcomes and safety. Patients will undergo catheter ablation with approved mapping and ablation catheters. The procedure includes sedation or anesthesia, vascular access through femoral or subclavian veins, and creation of electrical isolation around the pulmonary veins using the QDot Micro catheter at specified power and duration settings. Mapping catheters will verify effective isolation and identify any vein reconnections for additional treatment. Post-procedure assessments include ECG and optional echocardiograms to check for complications. After the ablation, participants will have regular follow-ups at 3 months and detailed evaluations up to 12 months, including physical exams, ECGs, and 24-hour Holter monitoring to detect arrhythmia recurrence. The study will measure the relationship between clinical and procedural details and arrhythmia recurrence rates, with safety and efficacy monitored throughout. Freedom from atrial fibrillation symptoms during follow-up indicates successful treatment.

Researchers are evaluating the HeartInsight algorithm, designed to predict acute heart failure events in patients with implanted Biotronik ICD or CRT-D devices that have atrial sensing and Home Monitoring. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. HeartInsight analyzes trends in seven physiological variables to provide early warnings of worsening heart failure, with a median lead time of 42 days. This study aims to assess how HeartInsight alerts are managed in routine clinical practice across multiple centers in Italy. About 100 patients will be enrolled across 14 centers and followed for 12 months. Participants have implanted devices with Home Monitoring and will be monitored remotely. When HeartInsight generates an alert, a standardized workflow guides clinical responses such as device adjustments, therapy optimization, unscheduled visits, or hospital admissions. The study collects data on alert frequency, clinical actions triggered, and patient use of the HeartInsight Patient App. Participants will provide informed consent and undergo standard remote monitoring and clinical visits. Data will be gathered through electronic case report forms, focusing on the proportion of alerts that lead to clinical actions, alert patterns, hospitalizations, and app usage. Safety and data quality will be monitored throughout. The study results aim to improve integration of predictive monitoring into patient care, potentially enhancing management and outcomes for heart failure patients.

Hydra-IT is a multicenter observational study conducted in various centers across Italy. It focuses on patients with severe symptomatic aortic valve stenosis, including those with degeneration of a native or bioprosthetic aortic valve. The study aims to evaluate the safety, effectiveness, and clinical outcomes of the Hydra Transcatheter Aortic Valve System in these patients. Additionally, it will assess long-term results and quality of treatment for up to five years. The Hydra device used in this study is a self-expanding transcatheter aortic valve made of a nitinol frame with three bovine pericardial leaflets positioned above the annulus. Patients will undergo transcatheter aortic valve implantation (TAVI) with this device. The study does not involve randomization or comparison groups but collects detailed clinical and procedural data on participants treated with the Hydra system. Participants will be monitored through clinical follow-ups to assess cardiovascular mortality within 30 days and longer-term outcomes for up to five years. Data collection includes procedural details, clinical status, and quality of life measures. Researchers will observe the safety and effectiveness of the device during this period. The total participation duration varies, with long-term follow-up planned to capture medium and long-term results.

Researchers are comparing two types of drug-coated balloons, Selution sirolimus coated balloon and SeQuent Please Neo paclitaxel coated balloon, for treating new coronary artery lesions in medium-small vessels measuring between 2.00 mm and 3.00 mm. The study aims to evaluate the angiographic outcomes, specifically the Net Gain in the treated area and Fractional Flow Reserve (FFR), over a 12-month follow-up period. This prospective, randomized, multicenter study focuses on patients with stable angina or stabilized acute coronary syndromes and involves only one lesion per patient, with specific inclusion criteria based on vessel size and lesion characteristics. Participants will be randomized 1:1 to receive either the sirolimus or paclitaxel coated balloon after successful lesion preparation. The study ensures treatment of other non-study lesions before the study lesion if present, with any necessary commercial devices. Follow-up includes phone calls at 1 and 6 months, and a mandatory angiographic and FFR assessment at 12 months at the same site as the initial procedure. Patients will receive dual anti-platelet therapy for at least one month following the procedure, then aspirin alone indefinitely, with adjustments if recent acute coronary syndrome or additional stents are involved. During the study, assessments include quantitative coronary angiography before and after the procedure and during follow-up, as well as FFR measurements at follow-up angiography. The researchers will monitor the treated vessel's condition and heart function, tracking safety and efficacy outcomes. The total study duration includes the initial procedure, follow-ups at 1 and 6 months by phone, and a 12-month angiographic follow-up, ensuring comprehensive evaluation of treatment outcomes and patient health over time.

Researchers are evaluating clinical outcomes in patients aged 65 to 75 with symptomatic severe aortic stenosis. The study compares the Myval balloon-expandable transcatheter heart valve (THV) series to surgical bioprosthetic aortic valve replacement (SAVR). The goal is to show that the Myval THV outcomes are not worse than those of SAVR in this patient group. Participants will be randomly assigned to receive either the Myval balloon-expandable THV device through transcatheter aortic valve replacement or a surgical bioprosthetic valve available at the clinical site. This multinational, multicenter, open-label trial will include 1180 patients treated with either method. The treatments are delivered according to local heart team decisions, ensuring each method's feasibility and approval. Throughout the study, researchers will monitor safety and effectiveness using composite measures, including all-cause death, stroke, bleeding, kidney injury, rehospitalization for related events, and valve dysfunction. These outcomes will be assessed at 1 month and 1 year after the procedure. Additionally, a CT scan substudy will evaluate the feasibility of redo or valve-in-valve TAVR procedures without needing leaflet modification. Participants will be followed closely to track these outcomes and any safety concerns during the study period.

Researchers are evaluating the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) therapy in adults with symptomatic heart failure caused by systolic left ventricular dysfunction, despite receiving optimal medical treatment. This observational cohort study includes both retrospective and prospective aspects. It aims to determine the proportion of patients who experience improvement in their New York Heart Association (NYHA) class by at least one level after 12 months, reductions in hospitalizations and emergency visits, changes in quality of life using the Minnesota Living with Heart Failure Questionnaire, walking distance improvements, and differences in NT-proBNP levels. Participants either already have or will receive the CCM device called "OPTIMIZER Smart Mini," which is implanted with leads in the heart's right ventricle and optionally the right atrium. This programmable implantable pulse generator delivers electrical impulses to improve heart function. The device is intended for patients over 18 years with symptomatic heart failure and reduced left ventricular function who have not responded sufficiently to medical therapy. The study evaluates responses following implantation, guided by preimplantation low-dose Dobutamine stress echocardiography. During the study, participants' clinical status and heart function are monitored through echocardiographic tests, quality-of-life questionnaires, and walking tests over a 12-month follow-up. Researchers track hospitalizations, emergency visits, and biomarker levels as well. The primary outcome is the change in NYHA class from enrollment to study end. Safety and effectiveness data are collected as part of participants' routine medical care, with the goal of better understanding who benefits most from CCM therapy.

Researchers are evaluating the adjunctive effectiveness and safety of the TIVUS System in adults with hypertension. The study includes people with uncontrolled hypertension taking 0 to 2 different anti-hypertensive drugs, and those with controlled hypertension taking 1 to 2 anti-hypertensive drugs. Participants will stop their medications for a 4-week wash-out before the procedure and remain off medications for 2 months after the procedure. The study is international, multicenter, randomized, double-blind, and sham-controlled, aiming to assess treatment outcomes while participants are off medications initially and then resume medication if needed. Participants will be randomly assigned in a 2:1 ratio to receive either the TIVUS Renal Denervation System, which uses ultrasound energy to denervate renal sympathetic nerves via catheterization, or a sham procedure consisting of an angiogram. After 2 months, those with uncontrolled hypertension will restart medications following a protocol. Unblinding occurs at 6 months, and participants in the sham group with uncontrolled hypertension may cross over to the TIVUS procedure. All treated participants will be followed for up to 36 months. During the study, participants will undergo blood pressure monitoring to measure daytime ambulatory systolic blood pressure changes from baseline to 2 months post-procedure. Major adverse events will be tracked from baseline through 30 days and 6 months after the procedure. Assessments include blood pressure readings, renal imaging to confirm eligibility, and safety follow-up visits. Medication adherence, side effects, and procedural safety will be closely monitored throughout the study duration.