PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00293241
First received: February 16, 2006
Last updated: June 26, 2015
Last verified: June 2015
Results First Received: October 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cardiovascular Diseases
Intervention: Device: Managed Ventricular Pacing programmed ON/OFF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study start February 2006; last patient enrolled in August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were electronically randomized. 25 patients were excluded from analysis due to double entry (7) or no evidence of Patient Informed Consent Form (PIC) signed (18).

Reporting Groups
  Description
MVP ON Managed Ventricular Pacing programmed on
MVP OFF Managed Ventricular Pacing programmed off: conventional pacing

Participant Flow:   Overall Study
    MVP ON     MVP OFF  
STARTED     299     306  
COMPLETED     263     265  
NOT COMPLETED     36     41  
Lost to Follow-up                 9                 16  
Physician Decision                 23                 17  
Withdrawal by Subject                 4                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MVP ON Managed Ventricular Pacing programmed on
MVP OFF Managed Ventricular Pacing programmed off: conventional pacing
Total Total of all reporting groups

Baseline Measures
    MVP ON     MVP OFF     Total  
Number of Participants  
[units: participants]
  299     306     605  
Age  
[units: years]
Mean (Standard Deviation)
  75.1  (10.9)     74.3  (10.8)     74.7  (10.8)  
Gender  
[units: participants]
     
Female     125     115     240  
Male     174     191     365  



  Outcome Measures
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1.  Primary:   Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant   [ Time Frame: Implant to 2 years post-implant ]

2.  Secondary:   Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.   [ Time Frame: Implant to 2 years post-implant ]

3.  Secondary:   Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant   [ Time Frame: Implant to 2 years post-implant ]

4.  Secondary:   Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant   [ Time Frame: Implant to 2 years post-implant ]

5.  Secondary:   Ventricular Pacing Percentage   [ Time Frame: Implant to 2 years post-implant ]

6.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time   [ Time Frame: Implant to 2 years post-implant ]

7.  Secondary:   Change in New York Heart Association (NYHA) Functional Class   [ Time Frame: Baseline, one year and 2 year post-implant ]

8.  Secondary:   Change in Use of Anticoagulation   [ Time Frame: Implant to 2 years post-implant ]

9.  Secondary:   Change in the Use of Cardiovascular Medication Over Time   [ Time Frame: Implant to 2 years post-implant ]

10.  Secondary:   Incidence of High Voltage Therapies   [ Time Frame: Implant to 2 years post-implant ]

11.  Secondary:   Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant   [ Time Frame: Implant to 2 years post-implant ]

12.  Secondary:   Stroke   [ Time Frame: Implant to 2 years post-implant ]

13.  Secondary:   Number of Cardiovascular Related Hospitalizations   [ Time Frame: Implant to 4 years post-implant ]

14.  Secondary:   Duration of Cardiovascular Related Hospitalizations   [ Time Frame: Implant to 4 years post-implant ]

15.  Secondary:   Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients   [ Time Frame: Implant to 2 years post-implant ]

16.  Secondary:   Change in PR Interval, Change in QRS Duration and Change in P-wave Duration   [ Time Frame: Implant to 2 years post-implant ]

17.  Secondary:   Patient Symptoms   [ Time Frame: Implant to 2 years post-implant ]

18.  Secondary:   Atrial Pacing Percentage   [ Time Frame: 2 years post-implant ]

19.  Secondary:   Health State   [ Time Frame: 2 years post-implant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Atrial pacing % was not collected at implant, device programming in the MVP off arm was more often non-compliant than in MVP on arm, and 25% of the case report forms were sent without device data, possibly influencing device data related objectives


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lidwien Vainer
Organization: Medtronic Bakken
phone: +31 433566752
e-mail: lidwien.vainer@medtronic.com


No publications provided


Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00293241     History of Changes
Other Study ID Numbers: Version 2-Aug 21, 2007
Study First Received: February 16, 2006
Results First Received: October 9, 2014
Last Updated: June 26, 2015
Health Authority: France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices