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

NCT ID: NCT04612335

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2025-06-30

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rate control

Intervention Type: OTHER

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

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.

Group Type: OTHER

Pharmacological or electrical cardioversion

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Dutch Heart Foundation

OTHER

Sponsor Role: collaborator

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry JG Crijns, MD, PhD

Role: STUDY_CHAIR

Head of cardiology department, Maastricht University Medical Center

Dominik Linz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of cardiac electrophysiology, Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands

Site Status: RECRUITING

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Site Status: RECRUITING

Rijnstate

Arnhem, , Netherlands

Site Status: RECRUITING

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status: RECRUITING

Martini Ziekenhuis

Groningen, , Netherlands

Site Status: RECRUITING

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Zuyderland Medisch Centrum

Heerlen, , Netherlands

Site Status: RECRUITING

Alrijne Ziekenhuis

Leiderdorp, , Netherlands

Site Status: RECRUITING

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status: RECRUITING

Radboud UMC

Nijmegen, , Netherlands

Site Status: RECRUITING

Antonius Ziekenhuis

Sneek, , Netherlands

Site Status: RECRUITING

St. Elisabeth TweeSteden Ziekenhuis

Tilburg, , Netherlands

Site Status: RECRUITING

VieCuri Medical Centre

Venlo, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Rachel MJ van der Velden, MD

Role: CONTACT

rachel.vander.velden@mumc.nl

31433876885

Nikki AH Pluymaekers, MD

Role: CONTACT

nikki.pluymaekers@mumc.nl

31433875119

Facility Contacts

Rachel van der Velden, MD

Role: primary

rachel.vander.velden@mumc.nl

+31433876885

S Timmer

Role: primary

O Kamp

Role: primary

M Hemels

Role: primary

J van Opstal

Role: primary

R Tieleman

Role: primary

I van Gelder

Role: primary

T Lenderink

Role: primary

C Kirchhof

Role: primary

V van Dijk

Role: primary

R Beukema

Role: primary

A Oomen

Role: primary

J Widdershoven

Role: primary

W Heesen

Role: primary

Other Identifiers

NL73104.068.20

Identifier Type: -

Identifier Source: org_study_id