Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure (POLAR-HF)

St. Josefs-Hospital Wiesbaden GmbH

Status

Completed

Conditions

Atrial Fibrillation

Cryoballon Ablation

Heart Failure

Treatments

Procedure: Cryoballoon Pulmonary Vein Isolation

Study type

Interventional

Funder types

Other

Identifiers

NCT04461691

POLAR-HF

Details and patient eligibility

About

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%).

Enrollment

1,420 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,420 participants in 2 patient groups

Heart Failure

Other group

Description:

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.

Treatment:

Procedure: Cryoballoon Pulmonary Vein Isolation

Normal cardiac function

Other group

Description:

Treatment:

Procedure: Cryoballoon Pulmonary Vein Isolation