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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: March 23, 2016
Last verified: March 2016
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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

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

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

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

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

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

14.  Secondary:   Development of Atrioventricular (AV) Block and Pacemaker Dependency   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 by ClinicalTrials.gov Identifier (NCT Number):

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: March 23, 2016
Health Authority: Italy: Ministry of Health