Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)
Recruiting
- Conditions
- Atrial fibrillation
- Registration Number
- NL-OMON22526
- Lead Sponsor
- MUMC+
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 490
Inclusion Criteria
Age > 18 years, ECG with atrial fibrillation, duration current episode <36 hours, symptoms due to AF, able and willing to sign informed consent, able and willing to use telemonitoring infrastructure
Exclusion Criteria
History of persistent AF, signs of myocardial infarction, signs of acute heart failure, hemodynamic instability, history of (untreated) sick sinus syndrome or Wolff-Parkinson-White syndrome, history of (unexplained) syncope, deemed unsuitable by attending physician, currently enrolled in another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of sinus rhythm on ECG after 4 weeks
- Secondary Outcome Measures
Name Time Method Implementation of the telemonitoring infrastructure, MACCE, AF recurrences/progression, cost-effectiveness, quality of life, patient reported outcome measures