Completed

Pulsed Field vs Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation with Heart Failure

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 99 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2025
See protocol details

Summary

Principal SponsorSt. Josefs-Hospital Wiesbaden GmbH
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure (a Propensity Score Matched Comparison)
NCT07181291
Principal SponsorSt. Josefs-Hospital Wiesbaden GmbH
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

700 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
Patients with paroxysmal or persistent AF and echocardiographically confirmed HFrEF (LVEF ≤ 40%)

Patients who underwent their first PVI using pulsed field or cryoballoon ablation as part of clinical routine

Patients with regular follow-up via 12-lead ECG or Holter ECG following PVI

Patients with at least three months of follow-up

3 exclusion criteria prevent from participating
Patients who did not undergo pulsed field or cryoballoon ablation for first-time PVI

Patients with LVEF > 40%

Patients who declined the use of their data during initial collection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Suspended

Vancouver General Hospital

Vancouver, CanadaOpen Vancouver General Hospital in Google Maps
Suspended

Montreal Heart Institute

Montreal, Canada
Suspended

Kerckhoff-Klinik Bad Nauheim

Bad Nauheim, Germany
Suspended

Vivantes Klinikum am Urban

Berlin, Germany
Completed12 Study Centers