Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 230
- Locations
- 20
- Primary Endpoint
- Ventricular pacing percentage
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Ventricular Pace Suppression (VpS)
The function Ventricular Pace Suppression (VpS) is activated
Intervention: Ventricular Pace Suppression (Vps) (Other)
Intrinsic Rhythm Support (IRSplus)
The function Intrinsic Rhythm Support (IRSplus) is activated
Intervention: Intrinsic rhythm support (IRSplus) (Other)
Outcomes
Primary Outcomes
Ventricular pacing percentage
Time Frame: 6 months
Secondary Outcomes
- Burden of atrial fibrillation(6 Months)
- Long-term atrio-ventricular conduction delay(6 Months)
- Occurrence of atrial tachycardia or atrial fibrillation events(6 Months)