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

NCT05508256 | Recruiting Phase 4 DMC

• 1 other identifier: CABA-HFPEF-DZHK27
• Study Type: interventional
• Target: 1,548
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

atrial fibrillation; heart failure; catheter ablation; medial therapy

Outcome Measures

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.

  Estimated first patient in to last patient out 48 months.

Secondary Outcomes (13)

• All-cause mortality

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

• Cardiovascular death

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

• Stroke

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

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

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

• Unplanned hospitalization for atrial arrhythmia

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

Study Arms (2)

Catheter Ablation

ACTIVE COMPARATOR

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.

Device: CE-marked Catheter Ablation

Usual Medical Care

NO INTERVENTION

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.

Interventions

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.

Catheter Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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%
• 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)
• 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

You may not qualify 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 interventional 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• Kompetenznetz Vorhofflimmern e.V. (AFNET): collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Charité University Medicine Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul Parwani, Dr.

  Head of Electrophysiology; Charité University Medicine Berlin, CVK

  PRINCIPAL INVESTIGATOR

• Paulus Kirchhof, Prof. Dr.

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

  STUDY CHAIR

• Stefan Kääb, Prof. Dr.

  Department of Cardiology, Ludwig-Maximilians-University Hospital Munich

  STUDY CHAIR

• Tim Friede, Prof. Dr.

  Departement of Medical Statistics, University Medical Center Göttingen

  STUDY CHAIR

• Roland Tilz, Prof. Dr.

  Head of Electrophysiology Department, University Hospital Lübeck

  STUDY CHAIR

• Burkert Pieske, Prof. Dr.

  Independent

  STUDY CHAIR

Central Study Contacts

Abdul Parwani, Dr.

CONTACT

+4930450565383; caba_hfpef@charite.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Electrophysiology

Model Details: The CABA-HFPEF is an investigator-initiated, prospective, parallel-group, randomized, open, blinded endpoint assessment, interventional multicenter strategy trial. CABA-HFPEF compares two treatment strategies that employ established therapies within their approved indications.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 19, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

DE (1)