Back to resultsVentricular Pace Suppression Versus Intrinsic Rhythm Support Study (VIPERS)
Primary Purpose
Sick Sinus Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ventricular Pace Suppression (Vps)
Intrinsic rhythm support (IRSplus)
Sponsored by
About this trial
This is an interventional treatment trial for Sick Sinus Syndrome focused on measuring Sick Sinus Syndrome, Ventricular pacing, Minimal ventricular pacing, Ventricular pacing suppression, Intrinsic rhythm support, Long term AV
Eligibility 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 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;
Sites / Locations
- Ospedale Bolognini
- P.O. F. Ferrari
- A.O. Destra Secchia
- Ospedale San Leonardo
- Ospedale SS. Trinità
- Ospedale SS. Cosma e Damiano
- Ospedale Santa Croce
- Ospedale S.Antonio Abate
- Ospedale Dell'Angelo
- A.O.U. Ospedali Riuniti di Ancona
- Ospedale Degli Infermi
- A.O.U. Policlinico-Vittorio Emanuele
- Ospedale S. Giuseppe
- Osp. Civile F. Veneziale
- P.O. Vito Fazzi
- A.O.R.N. dei Colli - PO "V. Monaldi"
- A.O. Santa Maria Degli Angeli
- A.O. San Carlo
- Ospedale Degli Infermi
- Ospedale SS. Giovanni e Paolo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ventricular Pace Suppression (VpS)
Intrinsic Rhythm Support (IRSplus)
Arm Description
The function Ventricular Pace Suppression (VpS) is activated
The function Intrinsic Rhythm Support (IRSplus) is activated
Outcomes
Primary Outcome Measures
Ventricular pacing percentage
Secondary Outcome Measures
Long-term atrio-ventricular conduction delay
Occurrence of atrial tachycardia or atrial fibrillation events
Burden of atrial fibrillation
Full Information
NCT ID
NCT01528657
First Posted
February 6, 2012
Last Updated
October 21, 2015
Sponsor
Biotronik SE & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT01528657
Brief Title
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
Acronym
VIPERS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome
Keywords
Sick Sinus Syndrome, Ventricular pacing, Minimal ventricular pacing, Ventricular pacing suppression, Intrinsic rhythm support, Long term AV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ventricular Pace Suppression (VpS)
Arm Type
Experimental
Arm Description
The function Ventricular Pace Suppression (VpS) is activated
Arm Title
Intrinsic Rhythm Support (IRSplus)
Arm Type
Experimental
Arm Description
The function Intrinsic Rhythm Support (IRSplus) is activated
Intervention Type
Other
Intervention Name(s)
Ventricular Pace Suppression (Vps)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intrinsic rhythm support (IRSplus)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventricular pacing percentage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Long-term atrio-ventricular conduction delay
Time Frame
6 Months
Title
Occurrence of atrial tachycardia or atrial fibrillation events
Time Frame
6 Months
Title
Burden of atrial fibrillation
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Capucci
Organizational Affiliation
A.O.U. Ospedali Riuniti, Ancona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valeria Calvi
Organizational Affiliation
A.O.U. Policlinico-Vittorio Emanuele, Catania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Brieda
Organizational Affiliation
A.O. Santa Maria degli Angeli, Pordenone
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ennio Pisanò
Organizational Affiliation
P.O. Vito Fazzi, Lecce
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vittorio Giudici
Organizational Affiliation
Ospedale Bolognini, Seriate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Bolognini
City
Seriate
State/Province
Bergamo
Country
Italy
Facility Name
P.O. F. Ferrari
City
Casarano
State/Province
Lecce
Country
Italy
Facility Name
A.O. Destra Secchia
City
Pieve di Coriano
State/Province
Mantova
Country
Italy
Facility Name
Ospedale San Leonardo
City
Castellammare
State/Province
Napoli
Country
Italy
Facility Name
Ospedale SS. Trinità
City
Borgomanero
State/Province
Novara
Country
Italy
Facility Name
Ospedale SS. Cosma e Damiano
City
Pescia
State/Province
Pistoia
Country
Italy
Facility Name
Ospedale Santa Croce
City
Moncalieri
State/Province
Torino
Country
Italy
Facility Name
Ospedale S.Antonio Abate
City
Gallarate
State/Province
Varese
Country
Italy
Facility Name
Ospedale Dell'Angelo
City
Mestre
State/Province
Venezia
Country
Italy
Facility Name
A.O.U. Ospedali Riuniti di Ancona
City
Ancona
Country
Italy
Facility Name
Ospedale Degli Infermi
City
Biella
Country
Italy
Facility Name
A.O.U. Policlinico-Vittorio Emanuele
City
Catania
Country
Italy
Facility Name
Ospedale S. Giuseppe
City
Empoli
Country
Italy
Facility Name
Osp. Civile F. Veneziale
City
Isernia
Country
Italy
Facility Name
P.O. Vito Fazzi
City
Lecce
Country
Italy
Facility Name
A.O.R.N. dei Colli - PO "V. Monaldi"
City
Napoli
Country
Italy
Facility Name
A.O. Santa Maria Degli Angeli
City
Pordenone
Country
Italy
Facility Name
A.O. San Carlo
City
Potenza
Country
Italy
Facility Name
Ospedale Degli Infermi
City
Rimini
Country
Italy
Facility Name
Ospedale SS. Giovanni e Paolo
City
Venezia
Country
Italy
12. IPD Sharing Statement
Citations:
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3711479
Citation
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Citation
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PubMed Identifier
2386214
Citation
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Citation
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Results Reference
derived
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Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
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