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Managed Ventricular Pacing ("MVP") Trial

This study has been terminated.
(Inability to reach statistical significance toward primary endpoint)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00281099
First received: January 20, 2006
Last updated: July 30, 2010
Last verified: July 2010
History of Changes
Results First Received: June 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Heart Disease
Intervention: Device: ICD (Implantable Cardioverter Defibrillator)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2051 subjects were screened for the study. Of the 2051 subjects screened, 1037 were enrolled in the study. 6 of 1037 subjects later failed to meet other qualifying inclusion criteria and were not randomized and assigned to a study arm.

Reporting Groups
  Description
VVI 40 Pacing Backup ventricular pacing at a rate of 40 beats per minute
MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute

Participant Flow:   Overall Study
    VVI 40 Pacing     MVP Pacing  
STARTED     513     518  
COMPLETED     308     296  
NOT COMPLETED     205     222  
Death                 46                 57  
Lost to Follow-up                 10                 19  
Withdrawal by Subject                 65                 70  
Physician Decision                 79                 72  
Heart Transplant/Device Exit/Changeout                 5                 4  



  Baseline Characteristics
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Reporting Groups
  Description
VVI 40 Pacing Backup ventricular pacing at a rate of 40 beats per minute
MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute
Total Total of all reporting groups

Baseline Measures
    VVI 40 Pacing     MVP Pacing     Total  
Number of Participants  
[units: participants]
 		  513     518     1031  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     289     284     573  
>=65 years     224     234     458  
Age  
[units: years]
Mean ± Standard Deviation 		  61.7  ± 11.7     62.6  ± 12.0     62.2  ± 11.9  
Gender  
[units: participants]
 		     
Female     108     104     212  
Male     405     414     819  
Region of Enrollment  
[units: participants]
 		     
France     3     3     6  
United States     390     390     780  
Canada     58     60     118  
Spain     2     3     5  
Austria     1     0     1  
Denmark     4     3     7  
Israel     14     15     29  
Germany     14     16     30  
United Kingdom     7     7     14  
Switzerland     9     9     18  
Italy     11     12     23  



  Outcome Measures
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1.  Primary:   All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.   [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) or death ]
  Show Outcome Measure 1

2.  Secondary:   Occurrence of Worsening Heart Failure-related Adverse Events   [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) ]
  Show Outcome Measure 2

3.  Secondary:   Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time   [ Time Frame: Baseline, 12, 24 and 36 month visits ]
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4.  Secondary:   Heart Chamber Dimensions and Wall Thicknesses   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 4

5.  Secondary:   Left Ventricular (LV) Ejection Fraction and Fractional Shortening   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 5

6.  Secondary:   Left Ventricular (LV) and Left Atrial (LA) Volumes   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 6

7.  Secondary:   Left Ventricular (LV) Sphericity Index   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 7

8.  Secondary:   Hemodynamic Velocity Measures   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 8

9.  Secondary:   Hemodynamic Deceleration Time   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 9

10.  Secondary:   Left Atrial (LA) and Mitral Regurgitation (MR) Areas   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 10

11.  Secondary:   Composite Mitral Regurgitation (MR) Severity Score   [ Time Frame: Baseline, 12, and 24 month visits ]
  Show Outcome Measure 11

12.  Secondary:   Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes   [ Time Frame: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) ]
  Show Outcome Measure 12

13.  Secondary:   Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History   [ Time Frame: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) ]
  Show Outcome Measure 13

14.  Secondary:   Development of a Pacing Indication During the Study   [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) ]
  Hide Outcome Measure 14

Measure Type Secondary
Measure Title Development of a Pacing Indication During the Study
Measure Description Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.
Time Frame Enrollment to last visit (up to 45 months post-randomization)  
Safety Issue No  

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.
1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Reporting Groups
  Description
VVI 40 Backup ventricular pacing at a rate of 40 beats per minute
MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute

Measured Values
    VVI 40     MVP Pacing  
Number of Participants Analyzed  
[units: participants]
 		  512     518  
Development of a Pacing Indication During the Study  
[units: participants]
 		  38     19  


Statistical Analysis 1 for Development of a Pacing Indication During the Study
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0053
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.



15.  Secondary:   Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction   [ Time Frame: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months ]
  Show Outcome Measure 15

16.  Secondary:   Percent Ventricular Pacing   [ Time Frame: Enrollment, 6, 12, 24 and 36 month visits ]
  Show Outcome Measure 16

17.  Secondary:   Quality of Life ("QOL") Score   [ Time Frame: Baseline, 12, 24, and 36 month visits ]
  Show Outcome Measure 17

18.  Secondary:   All Cause Mortality   [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) or death ]
  Show Outcome Measure 18

19.  Secondary:   ICD-indicated Patients With Class I Pacemaker Indication.   [ Time Frame: Period of time prior to patient consent when considering patient for Implant/Enrollment ]
  Show Outcome Measure 19


  Serious Adverse Events
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  Other Adverse Events
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  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: MVP Clinical Trial Leader
Organization: Medtronic, Inc.
e-mail: medtroniccrmtrials@medtronic.com


No publications provided by Medtronic Cardiac Rhythm Disease Management

Publications automatically indexed to this study:


Responsible Party: Steve Erickson, Principal Clinical Trial Leader, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00281099     History of Changes
Other Study ID Numbers: 240
Study First Received: January 20, 2006
Results First Received: June 30, 2009
Last Updated: July 30, 2010
Health Authority: United States: Institutional Review Board
Canada: Health Canada
European Union: European Medicines Agency