Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

NCT ID: NCT04461691

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-08-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Heart Failure Cryoballon Ablation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heart Failure

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.

Group Type OTHER

Cryoballoon Pulmonary Vein Isolation

Intervention Type PROCEDURE

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 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.

Group Type OTHER

Cryoballoon Pulmonary Vein Isolation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Josefs-Hospital Wiesbaden GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joachim Ehrlich, MD

Role: PRINCIPAL_INVESTIGATOR

St. Josefs-Hospital Wiesbaden GmbH

Andreas Boehmer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Josefs-Hospital Wiesbaden GmbH

Locations

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St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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POLAR-HF

Identifier Type: -

Identifier Source: org_study_id

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