Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.

Official Title
-----------------
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Device: DDD-CLS
* Device: ODO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by clinical diagnosis of reflex syncope who meet all the following 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 TT (according to the VASIS classification). Alternative therapies have failed or were not feasible. exclusion of other possible competitive causes of syncope. Exclusion Criteria: - Any other indication to IPG, 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; diagnosis of hypertrophic or dilated cardiomyopathy; clinically significant valvular disease; sinus bradycardia <50 bpm or sinoatrial block; Mobitz I second-degree atrioventricular block; Mobitz II second or third-degree atrioventricular block; bundle-branch block; rapid paroxysmal supraventricular tachycardia or ventricular tachycardia; preexcited QRS complexes; prolonged QT interval; Brugada syndrome; arrhythmogenic right ventricular cardiomyopathy 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DDD+CLS<br>The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. | Device: DDD-CLS<br> <br> |
| Placebo Comparator: ODO<br>The pacemaker will be programmed in ODO mode. | Device: ODO<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Recurrence of Syncopal Episode |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Recurrence of Pre-syncope or Syncope |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syncope, Closed Loop Stimulation, CLS