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

NCT ID: NCT05508256

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2027-07-31

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).

Detailed Description

HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.

Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.

No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.

Conditions

Atrial Fibrillation; Heart Failure With Preserved Ejection Fraction; Heart Failure With Mildly Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Catheter Ablation

Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Patients assigned to rhythm control group will be treated with catheter ablation as first line therapy to restore and maintain sinus rhythm, additionally to the therapeutic recommendations of the current ESC guidelines for the management of atrial fibrillation (AF) and the current ESC Heart Failure (HF) guidelines.

Group Type: ACTIVE_COMPARATOR

CE-marked Catheter Ablation

Intervention Type: 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.

Usual Medical Care

Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Subjects randomized to usual care will be treated according to current ESC guidelines for the management of AF and current ESC HF guidelines. Usual care of AF in the context of CABA-HFPEF consists of an initial treatment limited to rate control in addition to adequate antithrombotic therapy, typically oral anticoagulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CE-marked Catheter Ablation

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

Kompetenznetz Vorhofflimmern e.V. (AFNET)

UNKNOWN

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Abdul Parwani

Head of Electrophysiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul Parwani, Dr.

Role: PRINCIPAL_INVESTIGATOR

Head of Electrophysiology; Charité University Medicine Berlin, CVK

Paulus Kirchhof, Prof. Dr.

Role: STUDY_CHAIR

Director Department of Cardiology, Heart and Vascular Center University Hamburg Eppendorf

Stefan Kääb, Prof. Dr.

Role: STUDY_CHAIR

Department of Cardiology, Ludwig-Maximilians-University Hospital Munich

Tim Friede, Prof. Dr.

Role: STUDY_CHAIR

Departement of Medical Statistics, University Medical Center Göttingen

Roland Tilz, Prof. Dr.

Role: STUDY_CHAIR

Head of Electrophysiology Department, University Hospital Lübeck

Burkert Pieske, Prof. Dr.

Role: STUDY_CHAIR

Independent

Locations

Charité University Medicine Berlin, Campus Virchow Klinikum

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Abdul Parwani, Dr.

Role: CONTACT

caba_hfpef@charite.de

+4930450565383

Facility Contacts

Abdul Parwani, Dr.

Role: primary

caba_hfpef@charite.de

004930450565383

Other Identifiers

CABA-HFPEF-DZHK27

Identifier Type: -

Identifier Source: org_study_id