NCT04461691

Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,420 (actual)
• Sponsor: St. Josefs-Hospital Wiesbaden GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

• Atrial Fibrillation
• Heart Failure
• Cryoballon Ablation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2025-01-31
• Completion: 2025-08-31
• First posted: 2020-07-08
• Last updated: 2025-09-12

Locations

1 site across 1 country: Germany