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Compares treatment options for Atrial Fibrillation
Official title CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT05508256
What this study is testing
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Signed written informed consent
- Clinical evidence of symptomatic heart failure (NYHA Class II-III)
- Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG)
- Left ventricular ejection fraction (LVEF) 40-49% OR LVEF ≥ 50% with at least one of the following HFpEF echocardiography findings (any local...
You likely can't join if
- Patient is unable or unwilling to provide infomed consent
- Patient is not suitable for rhythm control of AF
- Previous left atrial CA or surgical therapy of AF
- Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
- Valvular heart disease needing treatment or surgical treatment within 3 months
- Heart surgery planned within 3 months
See the full eligibility criteria
- Age ≥18 years
- Signed written informed consent
- Clinical evidence of symptomatic heart failure (NYHA Class II-III)
- Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG)
- 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...
- 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...
- Patient is unable or unwilling to provide infomed consent
- Patient is not suitable for rhythm control of AF
- Previous left atrial CA or surgical therapy of AF
- Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
- Valvular heart disease needing treatment or surgical treatment within 3 months
- Heart surgery planned within 3 months
- Prior heart transplant or listed for heart transplant or cardiac assist device implantation
- Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled)
- Patient has absolute contra-indication to oral anticoagulation
- Any disease that limits life expectancy to less than 1 year
- Active systemic infection (after successful treatment of infection, patients may be enrolled)
- Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index \< 1%)
- Patient is included in another clinical trial
- Inability to comply with the study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.