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…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the primary endpoint is the presence of sinus rhythm on the electrocardiogram
(ECG) at 4 weeks.
Secondary outcome
Secondary endpoints are the number of transmissions from the telemonitoring
infrastructure, accuracy of the automatic red-amber-green alert system, AF
recurrences and progression, adverse events, costs, quality of life and
predictive value of extended electrocardiography for AF progression and
spontaneous conversion.
Background summary
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.
Study objective
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.
Study design
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.
Intervention
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.
Study burden and risks
the watchful-waiting approach may obviate the need for cardioversion, improve
resource utilization in EDs, avoid overtreatment with cardioversion and
therewith reduce disease burden. In addition to routine care, no additional
visits are required for patients in the interventional group. All patients will
be asked to use the telemetric monitoring device three times daily for four
weeks to guide rate control. Patients will be asked to fill out questionnaires
at baseline, and after 1, 6 and 12 months.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
• ECG with atrial fibrillation within 6 hours from presentation to the ED
• Duration of the 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04612335 |
| CCMO | NL73104.068.20 |