Back to resultsEVITA: Evaluation of VIP Feature in Pacemaker Patients
Primary Purpose
Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Device: St. Jude Medical Victory dual-chamber pacemaker
Ventricular Intrinsic Preference
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmia focused on measuring Patients with intact AV conduction
Eligibility Criteria
Inclusion Criteria: Patient has an indication for implantation of a dual-chamber pacemaker; Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature. Exclusion Criteria: Patient has persistent or permanent AF/AFl; Patient has permanent AV Block; Patient has a pacemaker replacement; Patient is in NYHA class IV; Patient is unable to attend the follow-up visits; Patient is pregnant; Patient is less than 18 years of age
Sites / Locations
- Universitätskliniken Heidelberg
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Ventricular Instrinsic Preference (VIP) turned ON
Ventricular Instrinsic Preference (VIP) turned OFF
Outcomes
Primary Outcome Measures
Percentage of ventricular pacing
Secondary Outcome Measures
Full Information
NCT ID
NCT00366158
First Posted
August 18, 2006
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00366158
Brief Title
EVITA: Evaluation of VIP Feature in Pacemaker Patients
Official Title
EVITA: Evaluation of VIP Feature in Pacemaker Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Patients with intact AV conduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ventricular Instrinsic Preference (VIP) turned ON
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ventricular Instrinsic Preference (VIP) turned OFF
Intervention Type
Device
Intervention Name(s)
Device: St. Jude Medical Victory dual-chamber pacemaker
Intervention Description
Pacemaker implant
Intervention Type
Device
Intervention Name(s)
Ventricular Intrinsic Preference
Intervention Description
Programming of pacemaker
Primary Outcome Measure Information:
Title
Percentage of ventricular pacing
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has an indication for implantation of a dual-chamber pacemaker;
Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.
Exclusion Criteria:
Patient has persistent or permanent AF/AFl;
Patient has permanent AV Block;
Patient has a pacemaker replacement;
Patient is in NYHA class IV;
Patient is unable to attend the follow-up visits;
Patient is pregnant;
Patient is less than 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Bauer, MD
Organizational Affiliation
Universitätskliniken Heidelberg, Heidelberg, 69115, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles Kennergren, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätskliniken Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26315154
Citation
Bauer A, Vermeulen J, Toivonen L, Voitk J, Barr C, Peytchev P. Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial. Herzschrittmacherther Elektrophysiol. 2015 Dec;26(4):359-66. doi: 10.1007/s00399-015-0394-2. Epub 2015 Aug 28.
Results Reference
derived
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EVITA: Evaluation of VIP Feature in Pacemaker Patients
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