Pulsed Field vs Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation with Heart Failure
Data Collection
Collected from past medical records and data - RetrospectiveArrhythmias, Cardiac+3
+ Atrial Fibrillation
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.This study focuses on patients who have both atrial fibrillation (AF) and heart failure with reduced pumping ability of the heart, known as reduced ejection fraction. These patients face a high risk of heart-related problems. The study aims to evaluate two different treatments that use catheter-based pulmonary vein isolation (PVI) to control heart rhythm. These treatments could help reduce the chances of death and the need for hospital visits due to worsening heart failure. The study is important because it looks at a newer treatment method called pulsed-field ablation and compares it to an already established method, cryoballoon ablation, to see if the new method is just as safe and effective. The study is observational, meaning it looks at previously collected data from multiple centers to make the comparison. It uses a statistical method called propensity score matching to fairly compare the two treatment methods in similar patients. This means researchers will examine existing data from patients who have undergone one of these two procedures to assess and compare the outcomes. The researchers will be looking at data that has been anonymized, ensuring privacy for the patients involved. This approach allows for a comprehensive comparison without the need for new patient enrollments, thereby speeding up the process of determining the best treatment option for this high-risk group.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.700 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Montreal Heart Institute
Montreal, CanadaKerckhoff-Klinik Bad Nauheim
Bad Nauheim, GermanyVivantes Klinikum am Urban
Berlin, Germany