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

Primary Purpose

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

Status

Recruiting

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

CE-marked Catheter Ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, heart failure, catheter ablation, medial therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 12 months and not longer than 24 months, 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):
1. 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
2. Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1cm or relative wall thickness >0.42)
Patients with at least 1 of the following:
1. 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 not in AF or >600 pg/ml for patients in AF on screening ECG
2. NT-proBNP >300 pg/ml for patients not in AF or >900 pg/ml for patients in AF on screening ECG

Exclusion Criteria:

Patients 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 within 3 months
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)
Any disease that limits life expectancy to less than 1 year
Severe renal dysfunction (stage V, requiring dialysis)
Active infection
Women currently pregnant or breastfeeding
Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial
Women of childbearing potential without highly effective contraception (PEARL-Index < 1%),
Inability to comply with the study procedures

Sites / Locations

Charité University Medicine Berlin, Campus Virchow KlinikumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Catheter Ablation

Usual Medical Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All-cause mortality

Cardiovascular death

Stroke

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

Unplanned hospitalization for atrial arrhythmia

Total (first and recurrent) planned and unplanned cardiovascular hospitalizations

Nights spent in hospital

Days alive and out of hospital

Atrial fibrillation burden (percentage of AF at 12 months FU Holter ECG)

Change in left ventricular ejection fraction at 12 months FU

Change in NYHA class at 12 months FU

Change in EHRA score at 12 months FU

Change in quality of life at 12 months FU

Full Information

NCT ID

NCT05508256

First Posted

August 10, 2022

Last Updated

March 3, 2023

Sponsor

Charite University, Berlin, Germany

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Kompetenznetz Vorhofflimmern e.V. (AFNET), Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05508256

Brief Title

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

Acronym

CABA-HFPEF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Kompetenznetz Vorhofflimmern e.V. (AFNET), Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

atrial fibrillation, heart failure, catheter ablation, medial therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Catheter Ablation

Arm Type

Active Comparator

Arm Description

Arm Title

Usual Medical Care

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

CE-marked Catheter Ablation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

All-cause mortality

Time Frame