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

Completed

• Conditions: Syncope; Signs and Symptoms; Syncope and collapse

• Registration Number: ISRCTN29754044
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Quality of life<br>2. Cost-analysis