Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05508256

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

Led by Charite University, Berlin, Germany · Updated on 2023-03-06

1548

Participants Needed

1

Research Sites

226 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

D

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed written informed consent
  • Clinical evidence of symptomatic heart failure (NYHA Class II-III)
  • Paroxysmal or persistent atrial fibrillation diagnosed less than 24 months ago, confirmed by at least one 12-lead ECG
  • Left ventricular ejection fraction (LVEF) 40-49% OR LVEF 50% or higher with at least one of the following echocardiography findings: LA enlargement (LA width 23.8 cm, LA length 5.0 cm, LA area 20 cm2, LA volume 55 ml, or LA volume index 9 ml/m2) or left ventricular hypertrophy (septal or posterior wall thickness 1.1 cm or relative wall thickness >0.42)
  • At least one of the following: HF hospitalization within 6 months before screening with NT-proBNP >200 pg/ml for patients in sinus rhythm or >600 pg/ml for patients in atrial fibrillation at blood sampling; OR NT-proBNP >300 pg/ml for patients in sinus rhythm or >900 pg/ml for patients in atrial fibrillation on screening ECG
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Not suitable for rhythm control of atrial fibrillation
  • Previous left atrial catheter ablation or surgical therapy for atrial fibrillation
  • Acutely decompensated heart failure, NYHA Class IV (may enroll after stabilization)
  • Valvular heart disease requiring interventional or surgical treatment within 3 months
  • Planned heart surgery within 3 months
  • Prior heart transplant, listed for transplant, or cardiac assist device implantation
  • Untreated hypothyroidism or hyperthyroidism (may enroll after treatment)
  • Absolute contraindication to oral anticoagulation
  • Any disease limiting life expectancy to less than 1 year
  • Active systemic infection (may enroll after treatment)
  • Women who are pregnant, breastfeeding, or of childbearing potential without highly effective contraception
  • Participation in another clinical trial
  • Inability to comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Charité University Medicine Berlin, Campus Virchow Klinikum

Berlin, Germany, 13353

Actively Recruiting

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Research Team

A

Abdul Parwani, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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