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Patients with atrial fibrillation (AF) and heart failure with reduced left ventricular ejection fraction (HFrEF) are at particularly high cardiovascular risk. Rhythm-control by means of catheter-based pulmonary vein isolation (PVI) reduces all-cause mortality and rehospitalization for worsening heart failure in these patients. Considering the globally increasing use of the novel "pulsed-field ablation", it is necessary to determine whether this technique can be performed with the same safety and efficacy as the established cryoballoon ablation (CRYO) in this critically ill patient population.
This retrospective, international, multicenter study compares the efficacy and safety of PFA versus CRYO in patients with AF and HFrEF (LVEF ≤40%) undergoing a first-time PVI-only procedure.
Using propensity-score matching to minimize selection bias, the study will retrospectively evaluate whether a non-thermal PFA approach is non-inferior to the established thermal CRYO technique regarding rhythm control, while comparing procedural safety and efficiency in this high-risk population. Non-inferiority is tested against the assumption of a 12-month recurrence rate of 30% with a prespecified non-inferiority margin of 12% (corresponding to a hazard ratio of 1.53).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon pulmonary-vein isolation | Electrical isolation of the pulmonary-veins using cryoenergy |
| |
| Pulsed field pulmonary-vein isolation | Electrical isolation of the pulmonary-veins using pulsed field energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI | Procedure | pulmonary-vein isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention | First documented clinical recurrence of any atrial arrhythmia | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a rehospitalization (≥ 1 night) due to atrial arrhythmia/ re-ablation or electrical cardioversion starting from day 1 post index procedure | 12 months | |
| Number of patients with a rehospitalization (≥ 1 night) due to worsening heart failure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with atrial fibrillation and heart failure (LVEF ≤ 40%)
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Ehrlich, MD | St. Josefs-Hospital Wiesbaden GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | Canada | |||
| Montreal Heart Institute |
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| 12 months |
| Death from any cause | 12 months |
| Number of subjects with procedure-associated complications | Death, Major bleeding (criteria per Bleeding Academic Research Consortium ≥2, treatment-requiring groin complications (including AV fistula, aneurysm, or dissection), pericardial effusion/tamponade, non-fatal stroke/transient ischemic, attack, temporary or persistent phrenic nerve palsy, homeless | 30 days |
| Montreal |
| Quebec |
| Canada |
| Kerckhoff-Klinik Bad Nauheim | Bad Nauheim | Germany |
| Vivantes Klinikum am Urban | Berlin | Germany |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | Germany |
| Universitätsklinikum Frankfurt am Main | Frankfurt am Main | Germany |
| Klinikum Fürth | Fürth | Germany |
| Evangelisches Krankenhaus Hagen-Haspe | Hagen | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg-Eppendorf | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| St. Josefs-Hospital Wiesbaden | Wiesbaden | Germany |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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