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CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction

ConditionsAtrial FibrillationHeart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection Fraction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CE-marked Catheter Ablation

    Device

    Once patients have been randomized to the catheter ablation (CA) group, the ablation procedure must be performed within 4 weeks. CA will initially aim at pulmonary vein isolation.

Treatment groups

1,548 Participants
are divided into 2 treatment groups
Group A: Catheter AblationActive comparator 1 intervention
Group B: Usual Medical CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome.

Time frame
Estimated first patient in to last patient out 48 months.

Secondary outcomes

1

All-cause mortality

Time frame
The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
2

Cardiovascular death

Time frame
The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
3

Stroke

Time frame
The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months
4

Total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome

Time frame
The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Collaborator

Kompetenznetz Vorhofflimmern e.V. (AFNET)

Collaborator

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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