Implantable loop recorder for continuous beat-to-beat monitoring (REVEAL) versus conventional strategy in the analysis of syncope of unknown aetiology

ISRCTN	ISRCTN29754044
DOI	https://doi.org/10.1186/ISRCTN29754044
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr W. Wieling
Scientific

Academic Medical Center
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5669111
Email	w.wieling@amc.uva.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title
Study objectives	1. Compare the diagnostic yield and time to diagnosis of the REVEAL with the diagnostic yield and time to diagnosis of a conventional diagnostic approach 2. Test the hypothesis that REVEAL can improve quality of life
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Syncope
Intervention	Implantable loop recorders. Conventional strategy includes external loop recording, and (if necessary) repeating of 24 hours holter monitoring, echocardiography or exercise-ECG.
Intervention type	Other
Primary outcome measure	Diagnostic yield defined as number of patients with arrhythmias with symptoms + number of patients with sinus rhythm with symptoms divided by the total number of patients undergoing the test.
Secondary outcome measures	1. Quality of life 2. Cost-analysis
Overall study start date	01/01/2000
Completion date	31/07/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	85
Key inclusion criteria	1. No diagnosis after history, physical exam and ECG 2. No diagnosis after echocardiography 3. No diagnosis after 24 hours holter monitoring 4. No diagnosis after exercise-testing 5. Age >18 years, <80 years 6. At least one syncopal episode with trauma or 2 witnessed syncopal episodes 7. Informed consent
Key exclusion criteria	1. (Cardiac) High risk patients 2. Abnormal electrophysiological examination 3. Pace-maker or intra-cardiac defibrillator 4. Pregnancy 5. Not able to activate implantable loop recorder 6. Serious disease with life expectancy <2 years
Date of first enrolment	01/01/2000
Date of final enrolment	31/07/2003

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl
"ROR"	https://ror.org/03t4gr691

Charity

Dutch Heart Foundation (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)

Medtronic BV (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan