Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.

Conditions
-----------------
Sick Sinus Syndrome

Intervention / Treatment
-----------------
* Other: Ventricular Pace Suppression (Vps)
* Other: Intrinsic rhythm support (IRSplus)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age; Patient has proven informed consent; Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction; Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position; Stable medical situation; Stable geographical situation; Exclusion Criteria: Permanent or paroxysmal AV block ≥ II; Permanent Atrial fibrillation/Atrial flutter; Device Replacement; Patient with a poor echocardiographic window; Patient already implanted with the right ventricular lead not in the apical position; Subjects with a dual chamber pacemaker, implanted later than six months; Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%; Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes; VpS or IRSplus algorithm contraindications; Age < 18 years; Life expectancy < 12 months; Cardiac surgery planned within the FU period; Participation to another clinical investigation;

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventricular Pace Suppression (VpS)<br>The function Ventricular Pace Suppression (VpS) is activated | Other: Ventricular Pace Suppression (Vps)<br>* Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.<br>|
| Experimental: Intrinsic Rhythm Support (IRSplus)<br>The function Intrinsic Rhythm Support (IRSplus) is activated | Other: Intrinsic rhythm support (IRSplus)<br>* All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular pacing percentage |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term atrio-ventricular conduction delay |  | 6 Months | 
| Occurrence of atrial tachycardia or atrial fibrillation events |  | 6 Months | 
| Burden of atrial fibrillation |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sick Sinus Syndrome, Ventricular pacing, Minimal ventricular pacing, Ventricular pacing suppression, Intrinsic rhythm support, Long term AV