Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study (VIPERS)
This study is currently recruiting participants.
Verified September 2012 by Biotronik SE & Co. KG
Sponsor:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01528657
First received: February 6, 2012
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
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 AV conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.
| Condition | Intervention |
|---|---|
|
Sick Sinus Syndrome |
Other: Ventricular Pace Suppression (Vps) Other: Intrinsic rhythm support (IRSplus) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Biotronik SE & Co. KG:
Primary Outcome Measures:
- Ventricular pacing percentage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Long-term atrio-ventricular conduction delay [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Occurrence of atrial tachycardia or atrial fibrillation events [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Burden of atrial fibrillation [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ventricular Pace Suppression (VpS)
The function Ventricular Pace Suppression (VpS) is activated
|
Other: Ventricular 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.
|
|
Experimental: Intrinsic Rhythm Support (IRSplus)
The function Intrinsic Rhythm Support (IRSplus) is activated
|
Other: Intrinsic 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 RV lead in the apical position;
- Stable medical situation;
- Stable geographical situation;
Exclusion Criteria:
- Permanent or paroxysmal AV block ≥ II;
- Permanent AF/Afl;
- Device Replacement;
- Patient with a poor echocardiographic window;
- Patient already implanted with the RV 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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528657
Contacts
| Contact: Nicola Rovai | +393346379010 | nicola.rovai@biotronik.com |
| Contact: Francesco Chiusso | +393346777837 | francesco.chiusso@biotronik.com |
Locations
| Italy | |
| Ospedale Bolognini | Recruiting |
| Seriate, Bergamo, Italy | |
| Principal Investigator: Vittorio Giudici | |
| P.O. F. Ferrari | Recruiting |
| Casarano, Lecce, Italy | |
| Principal Investigator: Donato Melissano | |
| A.O. Destra Secchia | Recruiting |
| Pieve di Coriano, Mantova, Italy | |
| Principal Investigator: Mario Pasqualini | |
| Ospedale San Leonardo | Recruiting |
| Castellammare, Napoli, Italy | |
| Principal Investigator: Ciro Guastaferro | |
| Ospedale SS. Trinità | Not yet recruiting |
| Borgomanero, Novara, Italy | |
| Principal Investigator: Stefano Maffè | |
| Ospedale SS. Cosma e Damiano | Not yet recruiting |
| Pescia, Pistoia, Italy | |
| Principal Investigator: Massimo Lupetti | |
| Ospedale Santa Croce | Not yet recruiting |
| Moncalieri, Torino, Italy | |
| Principal Investigator: Catia Checchinato | |
| Ospedale S.Antonio Abate | Recruiting |
| Gallarate, Varese, Italy | |
| Principal Investigator: Daniela Orsida | |
| Ospedale Dell'Angelo | Not yet recruiting |
| Mestre, Venezia, Italy | |
| Principal Investigator: Michela Madalosso | |
| A.O.U. Ospedali Riuniti di Ancona | Not yet recruiting |
| Ancona, Italy | |
| Principal Investigator: Alessandro Capucci | |
| Ospedale Degli Infermi | Recruiting |
| Biella, Italy | |
| Principal Investigator: Marenna Biondino | |
| A.O.U. Policlinico-Vittorio Emanuele | Recruiting |
| Catania, Italy | |
| Principal Investigator: Valeria Calvi | |
| Ospedale S. Giuseppe | Not yet recruiting |
| Empoli, Italy | |
| Principal Investigator: Attilio Del Rosso | |
| Osp. Civile F. Veneziale | Recruiting |
| Isernia, Italy | |
| Principal Investigator: Bruno Castaldi | |
| P.O. Vito Fazzi | Recruiting |
| Lecce, Italy | |
| Principal Investigator: Francesco Magliari | |
| A.O.R.N. dei Colli - PO "V. Monaldi" | Recruiting |
| Napoli, Italy | |
| Principal Investigator: Gerardo Nigro | |
| Policlinico Universitario di Padova | Not yet recruiting |
| Padova, Italy | |
| Principal Investigator: Loira Leoni | |
| A.O. Santa Maria Degli Angeli | Recruiting |
| Pordenone, Italy | |
| Principal Investigator: Marco Brieda | |
| A.O. San Carlo | Not yet recruiting |
| Potenza, Italy | |
| Principal Investigator: Francesco Sisto | |
| Ospedale Degli Infermi | Not yet recruiting |
| Rimini, Italy | |
| Principal Investigator: Maurizio Mezzetti | |
| Ospedale SS. Giovanni e Paolo | Recruiting |
| Venezia, Italy | |
| Principal Investigator: Andrea Lo Presti | |
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
| Principal Investigator: | Alessandro Capucci | A.O.U. Ospedali Riuniti, Ancona |
| Principal Investigator: | Valeria Calvi | A.O.U. Policlinico-Vittorio Emanuele, Catania |
| Principal Investigator: | Marco Brieda | A.O. Santa Maria degli Angeli, Pordenone |
| Principal Investigator: | Ennio Pisanò | P.O. Vito Fazzi, Lecce |
| Principal Investigator: | Vittorio Giudici | Ospedale Bolognini, Seriate |
More Information
Publications:
| Responsible Party: | Biotronik SE & Co. KG |
| ClinicalTrials.gov Identifier: | NCT01528657 History of Changes |
| Other Study ID Numbers: | BA098 |
| Study First Received: | February 6, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Biotronik SE & Co. KG:
|
Sick Sinus Syndrome Ventricular pacing Minimal ventricular pacing |
Ventricular pacing suppression Intrinsic rhythm support Long term AV |
Additional relevant MeSH terms:
|
Sick Sinus Syndrome Arrhythmia, Sinus Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Heart Block Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013