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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure | Other | 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. |
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| Normal cardiac function | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measures (Number of recurrence) | 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 | 60 months |
| Primary Outcome Measures (number of safety events) | 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) | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures (number of deaths) | Number of all-cause death | 60 months |
| Secondary Outcome Measures (procedural success) | 2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Ehrlich, MD | St. Josefs-Hospital Wiesbaden GmbH | Principal Investigator |
| Andreas Boehmer, MD | St. Josefs-Hospital Wiesbaden GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Josefs-Hospital Wiesbaden GmbH | Wiesbaden | 65189 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41263723 | Derived | Boehmer AA, Rothe M, Andrade JG, Wiedenmann L, Spork P, Schneider KY, Nussbaum E, Keim C, Weiss P, Dobre BC, Feickert S, Ruckes C, Dyrda K, Kaess BM, Nattel S, Ehrlich JR. Pulmonary Vein Isolation Only for Atrial Fibrillation With Heart Failure (POLAR-HF). JACC Clin Electrophysiol. 2026 Feb;12(2):264-273. doi: 10.1016/j.jacep.2025.09.041. Epub 2025 Nov 20. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Open label
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| 60 months |
| Secondary Outcome Measures (rehospitalization) | 3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes | 60 months |
| Secondary Outcome Measures (procedure duration) | 4. Total procedure duration and left-atrial dwell time (in minutes) | 60 months |
| Secondary Outcome Measures (total time) | 5. Total fluoroscopy time (in minutes) | 60 months |
| Secondary Outcome Measures (total contrast use) | 6. Total contrast dye use (in milliliters) | 60 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |