Mercogliano

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 procedures overall safety and efficacy.

This research investigates the real-world use of 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 capabilities. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. The HeartInsight algorithm, validated in previous studies, monitors trends in seven physiological parameters to provide early warnings about worsening heart failure, aiming to improve patient management by alerting healthcare providers well in advance. Patients enrolled in this prospective, multicenter observational registry will be followed for 12 months across approximately 14 centers in Italy. The study does not require additional diagnostic tests beyond standard care. When HeartInsight issues an alert, a standardized workflow guides clinical responses such as device adjustments, therapy changes, or extra visits. Patients may also choose to use the HeartInsight Patient App to assist in monitoring. The study collects data on how often alerts occur, the clinical actions taken, patient interviews, and hospitalizations. Participants will have their device data remotely monitored and attend regular clinical visits as part of routine care. Researchers will track the proportion of alerts that lead to clinical actions and measure secondary outcomes like alert frequency, duration of alert periods, patient interviews, hospitalizations, and app usage. Data are collected securely via electronic forms and monitored for quality. The study aims to provide insights into integrating predictive monitoring tools into everyday practice to potentially enhance heart failure care over a 12-month period.

This research aims to collect clinical, procedural, and follow-up data to evaluate the short, medium, and long-term outcomes of the Hydra Transcatheter Aortic Valve System in patients with severe aortic valve stenosis. The study is observational and conducted at multiple centers in Italy. It focuses on patients with severe symptomatic native aortic valve stenosis or bioprosthetic degeneration needing treatment, assessing the safety and effectiveness of this device over time. The Hydra device studied is a self-expanding transcatheter aortic valve made with a nitinol frame and three bovine pericardial leaflets positioned supra-annularly. Patients enrolled will undergo transcatheter aortic valve implantation TAVI using this device. The study will observe participants over a long term, up to five years, to assess clinical outcomes and device performance. Participants will be monitored for cardiovascular mortality within 30 days as the primary outcome. Additional outcomes include all-cause mortality, stroke types, myocardial infarction, bleeding, vascular complications, kidney injury, pacemaker implantation, valve leak, valve area, valve gradient, and heart function classification tracked at intervals up to five years. The study involves regular clinical evaluations and follow-up visits to assess these outcomes and overall safety.

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 sized between greater than 2.00 mm and 3.00 mm. The study aims to evaluate differences in artery diameter improvement Net Gain and blood flow measurement Fractional Flow Reserve at 12 months after treatment. This multicenter, randomized study focuses on patients with small vessel coronary artery disease and stable or stabilized heart conditions. Participants will receive angioplasty using one of the two drug-coated balloons after successful lesion preparation. Patients are randomized 11 to either the sirolimus or paclitaxel balloon groups, stratified by balloon length less than 30 mm or 30 mm and longer. Other non-study lesions may be treated with standard devices if needed. Follow-ups include phone calls at 1 and 6 months, with an angiographic and blood flow assessment at 12 months at the original treatment center. During the study, participants will undergo imaging assessments before and after the procedure and at one year to measure artery narrowing and blood flow. Measurements include quantitative coronary angiography and fractional flow reserve. Dual antiplatelet therapy is required for at least one month post-procedure, followed by aspirin alone indefinitely. Researchers will monitor device and procedure success, heart-related events, and vessel health throughout the 12-month period.

This research aims to compare the clinical outcomes of the Myval balloon-expandable transcatheter heart valve THV series with those of surgical bioprosthetic aortic valve replacement SAVR in patients aged 65 to 75 years who have symptomatic severe aortic stenosis. The study is a prospective, randomized, multinational, multicenter, open-label trial including 1180 participants. It assesses whether the Myval THV is not worse than SAVR regarding safety and effectiveness. Participants are randomly assigned to receive either the Myval balloon-expandable THV or a surgical bioprosthetic valve available at the clinical site. The procedures involve either transcatheter aortic valve replacement TAVR using the Myval device or standard surgical aortic valve replacement SAVR. The study includes a CT scan sub-study at selected sites to evaluate the feasibility of valve re-interventions and valve performance. During the study, participants will be monitored for safety and efficacy outcomes including death, stroke, bleeding, kidney injury, rehospitalization, and valve function over periods ranging from 1 month to up to 10 years. Assessments include clinical evaluations, transthoracic echocardiograms, CT scans, and recording of adverse events. The research team will track valve hemodynamics, complications, and the need for interventions to understand long-term results and safety.

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 adequate medical treatment. This observational cohort study, both retrospective and prospective, focuses on subjects already receiving CCM as part of their regular care. The study aims to assess clinical response, hospitalizations, quality of life, walking distance, and changes in heart biomarkers over 12 months. Participants carry the OPTIMIZER Smart Mini CCM device, a programmable implantable pulse generator connected to leads in the heart. The study groups are defined by their response to low-dose dobutamine stress echocardiography before implantation, with one group showing a reduction of 15% or more in left ventricular end-systolic volume LVESV and the other less than 15%. The low-dose dobutamine test involves incremental infusions of the drug to assess heart contractile reserve. During the 12-month follow-up, researchers will monitor changes in New York Heart Association NYHA class, hospitalizations, quality of life using the Minnesota Living with Heart Failure Questionnaire, walking test distance, and NT-proBNP biomarker levels. Additional assessments include echocardiographic measures and recording adverse events, cardiac device implants, or surgery. This comprehensive monitoring helps evaluate the clinical and functional effects of CCM therapy over time.

The trial investigates the adjunctive effectiveness and safety of the TIVUS Renal Denervation System in adults with hypertension. It focuses on subjects with uncontrolled hypertension taking up to two different anti-hypertensive drugs who will stop these medications during the study, as well as subjects with controlled hypertension taking one to two anti-hypertensive drugs who also agree to a medication wash-out period. This international, multicenter, randomized, double-blind, sham-controlled study aims to evaluate blood pressure reduction and safety outcomes in these groups. Participants will undergo a 4-week medication wash-out period before receiving either the TIVUS Renal Denervation procedure or a sham angiogram procedure. After the procedure, subjects remain off anti-hypertensive medications for two months. Subjects with uncontrolled hypertension restart medications following a specific escalation protocol two months after the procedure. The sham procedure is minimally invasive, and unblinding occurs six months post-procedure, with crossover to the TIVUS treatment allowed for uncontrolled sham subjects. Those treated with TIVUS will be followed up to 36 months. Throughout the study, participants will have their blood pressure monitored using daytime ambulatory systolic blood pressure measurements and other blood pressure assessments. Researchers will also track major adverse events within 30 days and six months after the procedure. Participants will undergo renal imaging to confirm eligibility and will have follow-up visits for up to three years. The study carefully monitors safety, medication adherence, and blood pressure changes to evaluate the TIVUS systems performance.