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Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

NCT04461691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1420

Last updated 2025-09-12

No results posted yet for this study

Summary

The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤ 40%).

Conditions

Interventions

PROCEDURE

Cryoballoon Pulmonary Vein Isolation

Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.

Sponsors & Collaborators

  • St. Josefs-Hospital Wiesbaden GmbH

    lead OTHER

Principal Investigators

  • Joachim Ehrlich, MD · St. Josefs-Hospital Wiesbaden GmbH

  • Andreas Boehmer, MD · St. Josefs-Hospital Wiesbaden GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2025-01-31
Completion
2025-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461691 on ClinicalTrials.gov