Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04612335|
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : December 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Rate control Other: Pharmacological or electrical cardioversion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||490 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)|
|Actual Study Start Date :||November 16, 2020|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2025|
Experimental: Watchful waiting
the watchful-waiting approach consists of administration of rate control medication to obtain relief of symptoms and a heart rate <110 beats per minute, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy.
Other: Rate control
Rate control drugs are administered to obtain symptom relief and a heart rate of <110 bpm, followed by a 4-week telemonitoring period.
Routine care consists of the standard treatment for an acute episode of recent-onset symptomatic atrial fibrillation, namely acute or delayed cardioversion, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy.
Other: Pharmacological or electrical cardioversion
Pharmacological or electrical cardioversion is performed to achieve restoration of sinus rhythm, either acutely or in a wait-and-see approach, all within 48 hours, and followed by a 4-week telemonitoring period.
- Presence of sinus rhythm [ Time Frame: 4 weeks after inclusion ]Sinus rhythm documented on a 12-lead ECG
- Implementation of the telemonitoring infrastructure [ Time Frame: 4 weeks ]e.g. use of telemonitoring infrastructure during the 4 weeks follow up, accuracy of alert system
- MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events [ Time Frame: 1 year ]e.g. hospitalisation for stroke, myocardial infarction
- AF recurrences/AF progression [ Time Frame: 4 weeks and 1 year ]e.g. number of AF recurrences, progression to persistent AF
- Cost-effectiveness [ Time Frame: 1 year ]The costs and cost-effectiveness of the new approach will be determined and compared to the costs and cost-effectiveness of routine care.
- Questionnaires on quality of life (SF-36) [ Time Frame: 1 year ]Questionnaires on quality of life (e.g. SF-36), will be used to assess whether there are differences between the two arms. The SF-36 will be evaluated according to recommendations; scores will be recoded on a scale of 0-100 and averaged. Higher scores indicate better quality of life.
- Patient reported experiences [ Time Frame: 1 year ]A questionnaire on patient reported experiences with the telemonitoring device will be used to assess whether there are differences between the two arms. There will be both positively orientated, and negatively orientated questionnes which have to be rated on a scale of 1-5.
- Rate and rhythm control interventions (number of) [ Time Frame: 4 weeks ]Alert- and patient-triggered
- Rhythm control interventions [ Time Frame: 1 year ]Number of participants with cardioversion, catheter ablation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612335
|Contact: Rachel MJ van der Velden, MDfirstname.lastname@example.org|
|Contact: Nikki AH Pluymaekers, MDemail@example.com|
|Maastricht University Medical Center||Recruiting|
|Maastricht, Limburg, Netherlands, 6229AX|
|Contact: Rachel van der Velden, MD +31433876885 firstname.lastname@example.org|
|Alkmaar, Noord-Holland, Netherlands, 1815JD|
|Contact: S Timmer|
|Vrije Universiteit Medisch Centrum||Recruiting|
|Contact: O Kamp|
|Contact: M Hemels|
|Medisch Spectrum Twente||Recruiting|
|Contact: J van Opstal|
|Contact: R Tieleman|
|Universitair Medisch Centrum Groningen||Recruiting|
|Contact: I van Gelder|
|Zuyderland Medisch Centrum||Recruiting|
|Contact: T Lenderink|
|Contact: C Kirchhof|
|St Antonius Ziekenhuis||Recruiting|
|Contact: V van Dijk|
|Contact: R Beukema|
|Contact: A Oomen|
|St. Elisabeth TweeSteden Ziekenhuis||Recruiting|
|Contact: J Widdershoven|
|VieCuri Medical Centre||Recruiting|
|Contact: W Heesen|
|Study Chair:||Harry JG Crijns, MD, PhD||Head of cardiology department, Maastricht University Medical Center|
|Principal Investigator:||Dominik Linz, MD, PhD||Head of cardiac electrophysiology, Maastricht University Medical Center|