Condition category
Signs and Symptoms
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr W. Wieling

ORCID ID

Contact details

Academic Medical Center
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5669111
w.wieling@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2000

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

85

Participant 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

Recruitment start date

01/01/2000

Recruitment end date

31/07/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Charity

Funder name

Dutch Heart Foundation (Netherlands)

Alternative name(s)

Dutch Heart Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Medtronic BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes