CRyoballoon Ablation versus mediCal thErapy in patients with Heart Failure and atrial fibrillation: A multicenter randomized clinical trial, the RACE-8-HF trial

Recruiting

Conditions: Atrial fibrillation
heart failure
10007521
10007593

Registration Number: NL-OMON54958

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 64

Inclusion Criteria

- Patients aged 18-80;
- HF with ejection fraction <50%, as assessed by recent (<6 months)
echocardiography,
cardiovascular magnetic resonance imaging (CMR) or other cardiac imaging;
- Documented AF;
- 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 persistent AF (> 1 year uninterrupted AF) or permanent AF;
- Asymptomatic patients;
- Previous pulmonary vein isolation or surgical ablation;
- Impaired renal function, defined as estimated glomerular filtration rate
(eGFR) <=25 ml/min/1.73m2;
- Recent (<90 days) acute coronary syndrome, cardiac intervention, 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;
- Known allergy for contrast, contraindication for cryoballoon ablation, or
other conditions that may prevent subjects from adhering to the trial protocol,
in the opinion of the investigator.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a combined endpoint of all-cause mortality, unplanned<br /><br>cardiovascular hospitalization, and stroke (time-to-event analysis).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary outcome measures are a combined endpoint of mortality, number of<br /><br>unplanned cardiovascular hospitalizations, and stroke (recurrent-event<br /><br>analysis); a hierarchical endpoint of mortality, unplanned cardiovascular<br /><br>hospitalizations, stroke, and HF complaints; and cost-effectiveness.</p><br>