MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00262119
First received: December 4, 2005
Last updated: May 9, 2014
Last verified: May 2014
Results First Received: May 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Heart Failure, Congestive
Intervention: Device: Pacemaker Medtronic EnRhythm

  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
The recruitment period was between February 2006 and April 2010. Patients were enrolled in cardiology departments.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1300 patients were enrolled in the study. Enrollment was followed by a 1-month run-in period. Patients with ventricular pacing ≥ 95% on device check in the run-in period were excluded from the study. At the end of the run-in period, randomization was performed. In all, 1166 patients were randomized and followed up.

Reporting Groups
  Description
Control Group

PM programming according to actual clinical practice

Pacemaker Medtronic EnRhythm: Pacemaker specific programming

MVP Only

PM programming according to actual clinical practice + MVP algorithm ON

Pacemaker Medtronic EnRhythm: Pacemaker specific programming

DDDRP

PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON

Pacemaker Medtronic EnRhythm: Pacemaker specific programming


Participant Flow:   Overall Study
    Control Group     MVP Only     DDDRP  
STARTED     385     398     383  
COMPLETED     327     328     325  
NOT COMPLETED     58     70     58  
Lost to Follow-up                 38                 51                 42  
Death                 20                 19                 16  



  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
Control Group

PM programming according to actual clinical practice

Pacemaker Medtronic EnRhythm: Pacemaker specific programming

MVP Only

PM programming according to actual clinical practice + MVP algorithm ON

Pacemaker Medtronic EnRhythm: Pacemaker specific programming

DDDRP

PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON

Pacemaker Medtronic EnRhythm: Pacemaker specific programming

Total Total of all reporting groups

Baseline Measures
    Control Group     MVP Only     DDDRP     Total  
Number of Participants  
[units: participants]
  385     398     383     1166  
Age  
[units: years]
Mean ± Standard Deviation
  73  ± 9     74  ± 9     74  ± 9     74  ± 9  
Gender  
[units: participants]
       
Female     180     188     210     578  
Male     205     210     173     588  
Region of Enrollment  
[units: participants]
       
Italy     203     211     202     616  
Netherlands     41     43     39     123  
Spain     16     18     17     51  
Portugal     43     44     44     131  
Austria     15     14     15     44  
France     0     1     1     2  
Germany     8     5     3     16  
Greece     23     25     25     73  
Hong Kong     1     1     1     3  
Israel     7     7     8     22  
Kuwait     2     4     3     9  
Russian Federation     10     11     9     30  
Slovakia     5     5     6     16  
Switzerland     9     7     7     23  
Taiwan     2     2     3     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years   [ Time Frame: 2 years ]

2.  Secondary:   Death for All Causes at 2 Years   [ Time Frame: 2 years ]

3.  Secondary:   Incidence of Permanent Atrial Fibrillation at 2 Years   [ Time Frame: 2 years ]

4.  Secondary:   Incidence of Cardiovascular Hospitalizations at 2 Years   [ Time Frame: 2 years ]

5.  Secondary:   Burden of Composite Clinical Endpoint   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Subjects' Symptoms   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Heart Failure Medications   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Cumulative Percentage of Ventricular Pacing   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Cardiovascular Death   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

10.  Secondary:   Any Hospitalization   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

11.  Secondary:   Atrial Fibrillation Burden   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

12.  Secondary:   Persistent Atrial Fibrillation (AF)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

13.  Secondary:   Adverse Events   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

14.  Secondary:   Development of Atrioventricular (AV) Block and Pacemaker Dependency   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

15.  Secondary:   Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

16.  Secondary:   Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

18.  Secondary:   Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

19.  Secondary:   Frequency, Type, and Associated Cost of Health Care Utilization and Utility   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Senior Clinical Research Manager
Organization: Medtronic
phone: 0039-0632814225
e-mail: andrea.grammatico@medtronic.com


Publications:

Publications automatically indexed to this study:

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00262119     History of Changes
Other Study ID Numbers: MNV-20-171005
Study First Received: December 4, 2005
Results First Received: May 9, 2014
Last Updated: May 9, 2014
Health Authority: Italy: Ministry of Health