Comparing watchful waiting to cardioversion for recent-onset atrial fibrillation
Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)
This study is testing if a watchful-waiting approach for recent-onset atrial fibrillation can work just as well as the usual treatment that includes heart rhythm restoration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 14 sites (Maastricht, Limburg and 13 other locations) |
| Trial ID | NCT04612335 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a watchful-waiting approach for patients with recent-onset atrial fibrillation (AF) compared to standard care that includes early or delayed cardioversion. Participants will receive rate control medication and be monitored for spontaneous conversion to sinus rhythm over a period of four weeks. The study is a multicenter, randomized, open-label trial designed to assess whether the watchful-waiting strategy can achieve similar outcomes to routine care. The total follow-up for participants will last one year, allowing for comprehensive assessment of AF behavior and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old experiencing symptomatic atrial fibrillation episodes lasting less than 36 hours.
Not a fit: Patients with a history of persistent atrial fibrillation or those with hemodynamic instability will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive cardioversion procedures, leading to better patient comfort and lower healthcare costs.
How similar studies have performed: Previous studies have indicated that a watchful-waiting approach can be effective, suggesting potential success for this trial's methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ECG with atrial fibrillation * Duration of the current AF episode \<36 hours * Symptoms due to atrial fibrillation * Age \> 18 years * Able and willing to sign informed consent * Able and willing to use telemetric rhythm recorder Exclusion Criteria: * History of persistent AF (episode of AF lasting more than 48 hours and terminated by cardioversion) * Deemed unsuitable for participation by attending physician * Hemodynamic instability (heart rate \>170 bpm, systolic blood pressure \<100 mmHg) * Acute heart failure * Signs of myocardial infarction * History of syncope of unexplained origin * History of untreated Sick Sinus Syndrome * History of untreated Wolff-Parkinson-White syndrome * Currently enrolled in another clinical trial
Where this trial is running
Maastricht, Limburg and 13 other locations
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
- Noordwest Ziekenhuisgroep — Alkmaar, Noord-Holland, Netherlands (Recruiting)
- Vrije Universiteit Medisch Centrum — Amsterdam, Netherlands (Recruiting)
- Rijnstate — Arnhem, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Zuyderland Medisch Centrum — Heerlen, Netherlands (Recruiting)
- Alrijne Ziekenhuis — Leiderdorp, Netherlands (Recruiting)
- St Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- Antonius Ziekenhuis — Sneek, Netherlands (Recruiting)
- St. Elisabeth TweeSteden Ziekenhuis — Tilburg, Netherlands (Recruiting)
- VieCuri Medical Centre — Venlo, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dominik Linz, MD, PhD — Head of cardiac electrophysiology, Maastricht University Medical Center
- Study coordinator: Rachel MJ van der Velden, MD
- Email: rachel.vander.velden@mumc.nl
- Phone: 31433876885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.