Status:
TERMINATED
Cryoballoon Ablation Versus Medical Therapy in Patients With Heart Failure and Atrial Fibrillation
Lead Sponsor:
Maastricht University
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Rationale: Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher morta...
Eligibility Criteria
Inclusion
- Patients aged 18-80;
- HF with ejection fraction \<40%, as assessed by recent (\<6 months) echocardiography or cardiovascular magnetic resonance imaging (CMR);
- AF, documented on standard ECG or Holter monitoring;
- Eligible for both treatment arms;
- Signed and dated informed consent prior to admission to the trial.
Exclusion
- End-stage heart failure: NYHA class IV, patients on waiting list for cardiac transplant and/or left ventricular assist device;
- Long-standing (\> 1 year) persistent or permanent AF;
- Previous pulmonary vein isolation or surgical ablation;
- Left atrial diameter ≥60 mm or left atrial volume index ≥50 ml/m2;
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) ≤25 ml/min/1.73m2;
- Recent (\<90 days) acute coronary syndrome, cardiac intervention1, or stroke/transient ischemic attack (TIA);
- Planned or expected cardiac surgery in the following year;
- Active infectious disease or malignancy;
- Women who are pregnant or planning to become pregnant during the trial;
- Contraindication for cryoballoon ablation or other condition that may prevent subjects from adhering to the trial protocol, in the opinion of the investigator.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04342832
Start Date
July 16 2020
End Date
April 19 2025
Last Update
July 25 2025
Active Locations (2)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
2
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX