Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Heart Failure; Cryoballon Ablation
• Interventions: Procedure: Cryoballoon Pulmonary Vein Isolation

• Registration Number: NCT04461691
• Lead Sponsor: St. Josefs-Hospital Wiesbaden GmbH

Brief 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%).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1402

Inclusion Criteria

• Symptomatic paroxysmal or persistent atrial fibrillation
• Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)
• Patients with normal cardiac function (assigned to control group)
• Age > 18 years
• Consent capacity

Exclusion Criteria

• Age under 18 years
• Pregnancy
• Lack of consent capacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart Failure	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.
Normal cardiac function	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.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures (number of safety events)	60 months	2. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)
Primary Outcome Measures (Number of recurrence)	60 months	Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures (number of deaths)	60 months	Number of all-cause death
Secondary Outcome Measures (total time)	60 months	5. Total fluoroscopy time (in minutes)
Secondary Outcome Measures (procedural success)	60 months	2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins
Secondary Outcome Measures (total contrast use)	60 months	6. Total contrast dye use (in milliliters)
Secondary Outcome Measures (rehospitalization)	60 months	3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes
Secondary Outcome Measures (procedure duration)	60 months	4. Total procedure duration and left-atrial dwell time (in minutes)

Trial Locations

Locations (1)

St. Josefs-Hospital Wiesbaden GmbH; 🇩🇪 Wiesbaden, Germany