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

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

Interventions

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

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.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Dutch Heart Foundation

  collaborator OTHER

• Netherlands Organisation for Scientific Research

  collaborator OTHER_GOV

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Harry JG Crijns, MD, PhD · Head of cardiology department, Maastricht University Medical Center

• Dominik Linz, MD, PhD · Head of cardiac electrophysiology, Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-16

Primary Completion

2024-06-30

Completion

2025-06-30

Countries

• Netherlands

Study Locations