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OpenTrials
Completed

NCT Number: NCT04461691

Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

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%).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Cryoballon Ablation Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoballoon Pulmonary Vein isolation

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.

Primary outcomes

  1. Primary Outcome Measures (Number of recurrence)

    Time frame: 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

  2. Primary Outcome Measures (number of safety events)

    Time frame: 60 months

    • 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)

Secondary outcomes

  1. Secondary Outcome Measures (number of deaths)

    Time frame: 60 months

    Number of all-cause death

  2. Secondary Outcome Measures (procedural success)

    Time frame: 60 months

    • Incidence of acute procedural success assessed by successful isolation of all pulmonary veins

  3. Secondary Outcome Measures (rehospitalization)

    Time frame: 60 months

    • Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes

  4. Secondary Outcome Measures (procedure duration)

    Time frame: 60 months

    • Total procedure duration and left-atrial dwell time (in minutes)

  5. Secondary Outcome Measures (total time)

    Time frame: 60 months

    • Total fluoroscopy time (in minutes)

  6. Secondary Outcome Measures (total contrast use)

    Time frame: 60 months

    • Total contrast dye use (in milliliters)

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Registry information

Acronym: POLAR-HF

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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