Cryoballoon Ablation Versus Medical Therapy in Patients With Heart Failure and Atrial Fibrillation

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    600
  • sponsor
    Maastricht University
Updated on 24 March 2021

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 mortality. Studies in HF patients in which the AF burden is reduced by AF ablation show promising results toward improved prognosis, but so far only one randomized trial is conducted that focused on major clinical endpoints. As the selected patients in this trial were not representative for the entire population and its ablation method varied from patient to patient, it is the aim of the present study to confirm that early invasive therapy consisting of a strict pulmonary vein isolation (PVI) protocol using cryoballoon therapy has positive effects on hard clinical endpoints in a wider variety of patients in the HF population.

Furthermore, there are no studies which compare cost-effectiveness of an early invasive strategy in this patient category. The investigators expect that avoided hospitalizations and healthcare resource utilizations lead to lower costs in the AF ablation group, despite initial higher costs of the procedure.

Objective

To compare outcome and cost-effectiveness of early AF ablation by PVI using cryoballoon therapy with standard (medical) therapy in patients with heart failure with reduced ejection fraction.

Study design:

Multicenter, randomized, open label clinical trial.

Study population:

Symptomatic adult patients with heart failure with reduced ejection fraction (<40%) and paroxysmal or persistent AF.

Intervention

AF ablation (PVI) using cryoballoon therapy.

Outcome measures:

The primary endpoint is a combined endpoint of all-cause mortality, unplanned cardiovascular hospitalization, and stroke (time-to-event analysis).

Secondary endpoints of the trial are:

  • A combined endpoint of mortality, number of unplanned cardiovascular hospitalizations, and stroke (recurrent-event analysis);
  • A hierarchical endpoint of mortality, unplanned cardiovascular hospitalizations, stroke, and HF complaints;
  • Cost-effectiveness. Key exploratory endpoints include individual components of the combined endpoints, days alive out of the hospital, hospitalizations for heart failure, recurrence of atrial arrhythmia, and quality of life.

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Heart failure, Congestive Heart Failure, Heart failure, Heart disease, Heart disease, Cardiac Disease, systolic heart failure, Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation (Pediatric), Congestive Heart Failure, Dysrhythmia, Cardiac Disease, cardiac failure, congestive heart disease
Treatment cryoballoon ablation
Clinical Study IdentifierNCT04342832
SponsorMaastricht University
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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