Ventricular Pace Suppression Study (VpS)
This study has been completed.
Sponsor:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01053832
First received: January 19, 2010
Last updated: October 24, 2011
Last verified: October 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2010 | ||||
| Last Updated Date | October 24, 2011 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01053832 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ventricular Pace Suppression Study | ||||
| Official Title ICMJE | Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker | ||||
| Brief Summary | Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm. |
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| Detailed Description | The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
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| Condition ICMJE | Pacemaker Indication | ||||
| Intervention ICMJE | Device: VpS algorithm in EVIA and ENTOVIS pacemakers
For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 84 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01053832 | ||||
| Other Study ID Numbers ICMJE | 45 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Biotronik SE & Co. KG | ||||
| Study Sponsor ICMJE | Biotronik SE & Co. KG | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Biotronik SE & Co. KG | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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