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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29754044

Enrollment

Registered

2005-12-19

Start date

2000-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope Signs and Symptoms Syncope and collapse

Interventions

Implantable loop recorders. Conventional strategy includes external loop recording, and (if necessary) repeating of 24 hours holter monitoring, echocardiography or exercise-ECG.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Quality of life 2. Cost-analysis	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026