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 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funders | Dutch Heart Foundation (Netherlands), Medtronic BV (Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Dr W. Wieling
Scientific
Scientific
Academic Medical Center
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| w.wieling@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Quality of life |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
