Benefit of dual-chamber pacing with Closed Loop Stimulation (CLS) in tilt-induced cardio-inhibitory reflex syncope. A randomized double-blind parallel trial.

Completed

• Conditions: Cardio-inhibitorisch reflex syncope; Tilt-Induced cardio-inhibitory reflex syncope; 10082206

• Registration Number: NL-OMON42000
• Lead Sponsor: Biotronik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

*Age >40 years.
*significant limitation of social and working life due to unpredictable or frequent syncope recurrences: *2 within the last year.
*type 2B cardio-inhibitory response to TTT (according
to the VASIS classification).
*alternative therapies have failed or are not feasible.
*exclusion of other possible competitive causes of syncope.

Exclusion Criteria

*Any other indication to IPG (pacemaker), implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines.
*Any cardiac dysfunctions possibly leading to loss of consciousness: overt heart failure; ejection fraction (LVEF) <40% (Echo-assessed within 3-month prior to study participation); myocardial infarction;...
*Symptomatic orthostatic hypotension diagnosed by standing BP measurement.
*Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
*Symptomatic cardioinhibitory carotid sinus hypersensitivity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Syncope</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pre-syncope</p><br>