Sick Sinus Syndrome
Conditions
Keywords
Sick Sinus Syndrome, Ventricular pacing, Minimal ventricular pacing, Ventricular pacing suppression, Intrinsic rhythm support, Long term AV
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.
Interventions
OTHERVentricular Pace Suppression (Vps)
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.
OTHERIntrinsic rhythm support (IRSplus)
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.
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventricular pacing percentage | 6 months |
Secondary
| Measure | 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 |
Countries
Italy
Outcome results
None listed