Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

Not Applicable

Completed

• Conditions: Sick Sinus Syndrome
• Interventions: Other: Ventricular Pace Suppression (Vps); Other: Intrinsic rhythm support (IRSplus)

• Registration Number: NCT01528657
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ventricular Pace Suppression (VpS)	Ventricular Pace Suppression (Vps)	The function Ventricular Pace Suppression (VpS) is activated
Intrinsic Rhythm Support (IRSplus)	Intrinsic rhythm support (IRSplus)	The function Intrinsic Rhythm Support (IRSplus) is activated

Primary Outcome Measures

Name	Time	Method
Ventricular pacing percentage	6 months

Secondary Outcome Measures

Name	Time	Method
Burden of atrial fibrillation	6 Months
Long-term atrio-ventricular conduction delay	6 Months
Occurrence of atrial tachycardia or atrial fibrillation events	6 Months

Trial Locations

Locations (19)

A.O. Destra Secchia; 🇮🇹 Pieve di Coriano, Mantova, Italy

A.O.U. Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

Ospedale Dell'Angelo; 🇮🇹 Mestre, Venezia, Italy

Ospedale S.Antonio Abate; 🇮🇹 Gallarate, Varese, Italy

Ospedale Bolognini; 🇮🇹 Seriate, Bergamo, Italy

Ospedale Degli Infermi; 🇮🇹 Rimini, Italy

A.O.U. Policlinico-Vittorio Emanuele; 🇮🇹 Catania, Italy

Ospedale S. Giuseppe; 🇮🇹 Empoli, Italy

A.O.R.N. dei Colli - PO "V. Monaldi"; 🇮🇹 Napoli, Italy

A.O. San Carlo; 🇮🇹 Potenza, Italy

Osp. Civile F. Veneziale; 🇮🇹 Isernia, Italy

Ospedale San Leonardo; 🇮🇹 Castellammare, Napoli, Italy

Ospedale Santa Croce; 🇮🇹 Moncalieri, Torino, Italy

A.O. Santa Maria Degli Angeli; 🇮🇹 Pordenone, Italy

P.O. Vito Fazzi; 🇮🇹 Lecce, Italy

Ospedale SS. Giovanni e Paolo; 🇮🇹 Venezia, Italy

Ospedale SS. Trinità; 🇮🇹 Borgomanero, Novara, Italy

P.O. F. Ferrari; 🇮🇹 Casarano, Lecce, Italy

Ospedale SS. Cosma e Damiano; 🇮🇹 Pescia, Pistoia, Italy