Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06560047

Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure

Led by Aalborg University Hospital · Updated on 2024-08-30

1616

Participants Needed

6

Research Sites

783 weeks

Total Duration

On this page

Sponsors

A

Aalborg University Hospital

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.

CONDITIONS

Official Title

Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Heart failure patients with atrial fibrillation within the past 12 months
  • Heart failure with reduced ejection fraction (HFrEF) clinically assessed
  • Indication for or ongoing guideline-directed medical therapy for HFrEF
  • Left ventricular ejection fraction below 50% within past 12 months
  • Symptomatic atrial fibrillation documented by ECG, Holter, or cardiac device
  • Asymptomatic atrial fibrillation with clinical indication for rhythm or rate control or multiple ECG-detected episodes or prolonged episodes on Holter or cardiac device
  • Age between 18 and 80 years
  • Receiving or planned uptitration of optimal medical therapy for HFrEF
  • On anticoagulation treatment for stroke prevention according to AF guidelines
Not Eligible

You will not qualify if you...

  • Life expectancy less than 1 year
  • Body mass index over 40
  • Contraindications or unacceptable side effects to rate limiting drugs and amiodarone
  • Left atrial size indexed for body surface area over 60 ml/m2 on recent echocardiography
  • Persistent or permanent atrial fibrillation over 1 year
  • Previous atrial fibrillation ablation or surgery
  • Reversible causes of atrial fibrillation such as recent infection, untreated thyroid disease, or surgery
  • Severe valvular heart disease
  • Acute myocardial infarction, cardiothoracic surgery, or stroke within past 3 months
  • Planned cardiothoracic surgery
  • Listed for heart transplant
  • Contraindications for anticoagulation or catheter ablation
  • Severe kidney disease (chronic kidney disease stage 5 or higher)
  • Pregnancy
  • Unwillingness to try medical therapy for atrial fibrillation
  • Unable or unwilling to give informed consent for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Aalborg University Hospital, Department of Cardiology

Aalborg, Denmark, 9000

Actively Recruiting

2

Aarhus University Hospital

Aarhus, Denmark, 8200

Not Yet Recruiting

3

Department of Cardiology, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

4

Department of Cardiology, Herlev-Gentofte University Hospital

Hellerup, Denmark, 2900

Actively Recruiting

5

Department of Cardiology, Odense University Hospital

Odense, Denmark, 5000

Not Yet Recruiting

6

Department of Cardiology, Zealand University Hospital

Roskilde, Denmark, 4000

Not Yet Recruiting

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Research Team

A

Anne-Christine Ruwald, MD, PhD

CONTACT

S

Sam Riahi, MD, PhD

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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