Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

Not Applicable

Completed

• Conditions: Sick Sinus Syndrome

• 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

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)

Ospedale Bolognini; 🇮🇹 Seriate, Bergamo, Italy

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

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

Ospedale San Leonardo; 🇮🇹 Castellammare, Napoli, Italy

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

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

Ospedale Santa Croce; 🇮🇹 Moncalieri, Torino, Italy

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

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

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

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