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

NCT04612335 | Recruiting DMC

• 1 other identifier: NL73104.068.20
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Cardiac arrhythmia; Cardioversion; Electrical cardioversion; Watchful waiting; Wait-and-see; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Presence of sinus rhythm

  Sinus rhythm documented on a 12-lead ECG

  4 weeks after inclusion

Secondary Outcomes (8)

• Implementation of the telemonitoring infrastructure

  4 weeks

• MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events

  1 year

• AF recurrences/AF progression

  4 weeks and 1 year

• Cost-effectiveness

  1 year

• Questionnaires on quality of life (SF-36)

  1 year

Study Arms (2)

Watchful waiting

EXPERIMENTAL

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

Routine care

OTHER

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

Interventions

Rate control OTHER

Rate control drugs are administered to obtain symptom relief and a heart rate of \<110 bpm, followed by a 4-week telemonitoring period.

Watchful waiting

Pharmacological or electrical cardioversion OTHER

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.

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Dutch Heart Foundation: collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (14)

Maastricht University Medical Center

Maastricht, Limburg, 6229AX, Netherlands

RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, 1815JD, 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

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Heart Rate; Electric Countershock

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Electric Stimulation Therapy; Therapeutics

Study Officials

• Harry JG Crijns, MD, PhD

  Head of cardiology department, Maastricht University Medical Center

  STUDY CHAIR

• Dominik Linz, MD, PhD

  Head of cardiac electrophysiology, Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel MJ van der Velden, MD

CONTACT

31433876885; rachel.vander.velden@mumc.nl

Nikki AH Pluymaekers, MD

CONTACT

31433875119; nikki.pluymaekers@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: November 2, 2020
• Study Start: November 16, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Well after publication of main paper
• Access Criteria: Please contact principal investigator or study chair.

Locations

NL (14)