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

Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Rate control; Other: Pharmacological or electrical cardioversion

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 490
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel MJ van der Velden, MD; Phone Number: 31433876885; Email: rachel.vander.velden@mumc.nl
• Study Contact Backup: Name: Nikki AH Pluymaekers, MD; Phone Number: 31433875119; Email: nikki.pluymaekers@mumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Vrije Universiteit Medisch Centrum
    • Contact: O Kamp
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate
    • Contact: M Hemels
  • Enschede, Netherlands
    • Recruiting
    • Medisch Spectrum Twente
    • Contact: J van Opstal
  • Groningen, Netherlands
    • Recruiting
    • Universitair Medisch Centrum Groningen
    • Contact: I van Gelder
  • Groningen, Netherlands
    • Recruiting
    • Martini Ziekenhuis
    • Contact: R Tieleman
  • Heerlen, Netherlands
    • Recruiting
    • Zuyderland Medisch Centrum
    • Contact: T Lenderink
  • Leiderdorp, Netherlands
    • Recruiting
    • Alrijne Ziekenhuis
    • Contact: C Kirchhof
  • Nieuwegein, Netherlands
    • Recruiting
    • St Antonius Ziekenhuis
    • Contact: V van Dijk
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud UMC
    • Contact: R Beukema
  • Sneek, Netherlands
    • Recruiting
    • Antonius Ziekenhuis
    • Contact: A Oomen
  • Tilburg, Netherlands
    • Recruiting
    • St. Elisabeth TweeSteden Ziekenhuis
    • Contact: J Widdershoven
  • Venlo, Netherlands
    • Recruiting
    • Viecuri Medical Centre
    • Contact: W Heesen
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229AX
      • Recruiting
      • Maastricht University Medical Center
      • Contact: Rachel van der Velden, MD; Phone Number: +31433876885; Email: rachel.vander.velden@mumc.nl
  • Noord-Holland
    • Alkmaar, Noord-Holland, Netherlands, 1815JD
      • Recruiting
      • Noordwest Ziekenhuisgroep
      • Contact: S Timmer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: Routine care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of sinus rhythm	Sinus rhythm documented on a 12-lead ECG	4 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of the telemonitoring infrastructure	e.g. use of telemonitoring infrastructure during the 4 weeks follow up, accuracy of alert system	4 weeks
MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events	e.g. hospitalisation for stroke, myocardial infarction	1 year
AF recurrences/AF progression	e.g. number of AF recurrences, progression to persistent AF	4 weeks and 1 year
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
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
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
Rate and rhythm control interventions (number of)	Alert- and patient-triggered	4 weeks
Rhythm control interventions	Number of participants with cardioversion, catheter ablation	1 year

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Dutch Heart Foundation; ZonMw: The Netherlands Organisation for Health Research and Development; Netherlands Organisation for Scientific Research
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Telemonitoring; Cardioversion; Watchful waiting; Cardiac arrhythmia; Electrical cardioversion; Wait-and-see
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NL73104.068.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All elements from the CRF matching a future project's CRF may be provided for an aggregated analysis.
• IPD Sharing Time Frame: Well after publication of main paper
• IPD Sharing Access Criteria: Please contact principal investigator or study chair.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No