POLAR-HF: Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Study Details
Study Description
Brief 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%).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: 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. |
Procedure: 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.
|
Other: 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. |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Primary Outcome Measures (Number of recurrence) [36 months]
Number of subjects with recurrence of atrial fibrillation or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure
- Primary Outcome Measures (number of safety events) [36 months]
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)
Secondary Outcome Measures
- Secondary Outcome Measures (number of deaths) [36 months]
Number of all-cause death
- Secondary Outcome Measures (procedural success) [36 months]
2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins
- Secondary Outcome Measures (rehospitalization) [36 months]
3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes
- Secondary Outcome Measures (procedure duration) [36 months]
4. Total procedure duration and left-atrial dwell time (in minutes)
- Secondary Outcome Measures (total time) [36 months]
5. Total fluoroscopy time (in minutes)
- Secondary Outcome Measures (total contrast use) [36 months]
6. Total contrast dye use (in milliliters)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Symptomatic paroxysmal or persistent atrial fibrillation
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Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)
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Patients with normal cardiac function (assigned to control group)
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Age > 18 years
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Consent capacity
Exclusion Criteria:
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Age under 18 years
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Pregnancy
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Lack of consent capacity
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | St. Josefs-Hospital Wiesbaden GmbH | Wiesbaden | Germany | 65189 |
Sponsors and Collaborators
- St. Josefs-Hospital Wiesbaden GmbH
Investigators
- Principal Investigator: Joachim Ehrlich, MD, St. Josefs-Hospital Wiesbaden GmbH
- Principal Investigator: Andreas Boehmer, MD, St. Josefs-Hospital Wiesbaden GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- POLAR-HF