Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

  • STATUS
    Recruiting
  • participants needed
    280
  • sponsor
    St. Josefs-Hospital Wiesbaden GmbH
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Updated on 16 February 2024
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heart failure
atrial fibrillation
radiofrequency ablation
persistent atrial fibrillation
fibrillation
pulmonary vein isolation

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%).

Details
Condition Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, atrial fibrillation (pediatric), Heart failure, Heart failure, Heart disease, Heart disease, atrial fibrillation (pediatric), Cryoballon Ablation
Age 18years - 99years
Treatment Cryoballoon Pulmonary Vein Isolation
Clinical Study IdentifierNCT04461691
SponsorSt. Josefs-Hospital Wiesbaden GmbH
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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