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

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612335
• Other study ID #: NL73104.068.20
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Maastricht University Medical Center
• Contact: Rachel MJ van der Velden, MD
• Phone: 31433876885
• Email: rachel.vander.velden[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed <48h) allows spontaneous conversion to sinus rhythm in 69% of patients, obviating active cardioversion. Recurrences within one month were seen in 30% of patients in both groups, i.e. the initially chosen strategy did not affect the recurrence pattern. Considering the latter, it remains unclear whether cardioversion is needed at all, especially since cardioversion strategy does not seem to affect behaviour of the arrhythmia over time. Instead of cardioversion a watchful-waiting rate control strategy may be appropriate as initial strategy. This allows observing the electrical and clinical behavior of arrhythmia, providing a solid basis for comprehensive and effective early rhythm control. This study is a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus routine care in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel telemonitoring infrastructure to guide rate control during follow-up.

Description:

Until recently standard of care for patients with recent-onset atrial fibrillation (AF) was early cardioversion. This has just been expanded with a delayed cardioversion approach. However, considering the recurrent and transient nature of AF, cardioversion might not be needed at all and rate control medication might be sufficient to accomplish spontaneous conversion to sinus rhythm. The aim of this trial is to evaluate effectiveness (presence of sinus rhythm) of a watchful-waiting approach, i.e. symptom reduction through rate-control medication and monitoring until spontaneous conversion is achieved compared to routine care, consisting of either early or delayed cardioversion. The trial is a multicentre prospective, randomized, open label, non-inferiority trial comparing the interventional watchful-waiting approach to routine care (control).The primary endpoint (presence of sinus rhythm), will be assessed after 4 weeks. The total follow-up time is 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar	Noord-Holland
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Rijnstate	Arnhem
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Alrijne Ziekenhuis	Leiderdorp
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	Radboud UMC	Nijmegen
Netherlands	Antonius Ziekenhuis	Sneek
Netherlands	St. Elisabeth TweeSteden Ziekenhuis	Tilburg
Netherlands	VieCuri Medical Centre	Venlo

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Heart Foundation, Netherlands Organisation for Scientific Research, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of sinus rhythm	Sinus rhythm documented on a 12-lead ECG	4 weeks after inclusion
Secondary	Implementation of the telemonitoring infrastructure	e.g. use of telemonitoring infrastructure during the 4 weeks follow up, accuracy of alert system	4 weeks
Secondary	MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events	e.g. hospitalisation for stroke, myocardial infarction	1 year
Secondary	AF recurrences/AF progression	e.g. number of AF recurrences, progression to persistent AF	4 weeks and 1 year
Secondary	Cost-effectiveness	The costs and cost-effectiveness of the new approach will be determined and compared to the costs and cost-effectiveness of routine care.	1 year
Secondary	Questionnaires on quality of life (SF-36)	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.	1 year
Secondary	Patient reported experiences	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.	1 year
Secondary	Rate and rhythm control interventions (number of)	Alert- and patient-triggered	4 weeks
Secondary	Rhythm control interventions	Number of participants with cardioversion, catheter ablation	1 year