NCT05508256 CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT05508256 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,548 participants |
| Start Date | 2023-03 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,548 participants in total. It began in 2023-03 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Eligibility Criteria
INCLUSION CRITERIA: 1. Age ≥18 years 2. Signed written informed consent 3. Clinical evidence of symptomatic heart failure (NYHA Class II-III) 4. Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG) 5. Left ventricular ejection fraction (LVEF) 40-49% OR LVEF ≥ 50% with at least one of the following HFpEF echocardiography findings (any local measurement made during the screening epoch): A. LA enlargement defined by at least 1 of the following: LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml/m2 B. Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1 cm or relative wall thickness \>0.42) 6. Patients with at least 1 of the following: A. HF hospitalization (defined as HF listed as the major reason for hospitalization) within 6 months prior to screening visit and NT-proBNP \>200 pg/ml for patients in sinus rhythm (SR) or \>600 pg/ml for patients in AF at the time of blood sampling B. NT-proBNP \>300 pg/ml for patients in SR or \>900 pg/ml for patients in AF on screening ECG EXCLUSION CRITERIA: 1. Patient is unable or unwilling to provide infomed consent 2. Patient is not suitable for rhythm control of AF 3. Previous left atrial CA or surgical therapy of AF 4. Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization) 5. Valvular heart disease needing interventional or surgical treatment within 3 months 6. Heart surgery planned within 3 months 7. Prior heart transplant or listed for heart transplant or cardiac assist device implantation 8. Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled) 9. Patient has absolute contra-indication to oral anticoagulation 10. Any disease that limits life expectancy to less than 1 year 11. Active systemic infection (after successful treatment of infection, patients may be enrolled) 12. Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index \< 1%) 13. Patient is included in another clinical trial 14. Inability to comply with the study procedures
Contact & Investigator
Abdul Parwani, Dr.
PRINCIPAL INVESTIGATOR
Head of Electrophysiology; Charité University Medicine Berlin, CVK
Frequently Asked Questions
Who can join the NCT05508256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05508256 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05508256 currently recruiting?
Yes, NCT05508256 is actively recruiting participants. Contact the research team at caba_hfpef@charite.de for enrollment information.
Where is the NCT05508256 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT05508256 clinical trial?
NCT05508256 is sponsored by Charite University, Berlin, Germany. The principal investigator is Abdul Parwani, Dr. at Head of Electrophysiology; Charité University Medicine Berlin, CVK. The trial plans to enroll 1,548 participants.
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