Atrial Fibrillation, Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
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).
Interventions
PROCEDUREPVI
pulmonary-vein isolation
Sponsors
St. Josefs-Hospital Wiesbaden GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with paroxysmal or persistent AF and echocardiographically confirmed HFrEF (LVEF ≤ 40%) 2. Patients who underwent their first PVI using pulsed field or cryoballoon ablation as part of clinical routine 3. Patients with regular follow-up via 12-lead ECG or Holter ECG following PVI 4. Patients with at least three months of follow-up
Exclusion criteria
1. Patients who did not undergo pulsed field or cryoballoon ablation for first-time PVI 2. Patients with LVEF \> 40% 3. Patients who declined the use of their data during initial collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with a clinical recurrence of any atrial arrhythmia (AF, atrial flutter, atrial tachycardia) occurring more than 8 weeks post-intervention | 12 months | First documented clinical recurrence of any atrial arrhythmia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 months | — |
| Death from any cause | 12 months | — |
| Number of subjects with procedure-associated complications | 30 days | 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 |
Countries
Canada, Germany
Contacts
PRINCIPAL_INVESTIGATORJoachim Ehrlich, MD
St. Josefs-Hospital Wiesbaden GmbH
Outcome results
None listed