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Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)

Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22526
Enrollment
490
Registered
2021-04-16
Start date
2020-11-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

Sponsors

MUMC+
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Presence of sinus rhythm on ECG after 4 weeks

Secondary

MeasureTime frame
Implementation of the telemonitoring infrastructure, MACCE, AF recurrences/progression, cost-effectiveness, quality of life, patient reported outcome measures

Contacts

Public ContactRachel van der Velden

Maastricht UMC+

rachel.vander.velden@mumc.nl043-3876885

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)