Optimize RV Follow-up Selective Site Pacing Clinical Trial (ORVFUP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00949715
First received: July 28, 2009
Last updated: July 23, 2013
Last verified: July 2013
Results First Received: March 11, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Cardiac Pacing
Right Ventricular Pacing
LVEF >/=40%
Interventions: Device: Medtronic or Vitatron Dual-Chamber Pacemaker
Device: Medtronic SelectSecure 3830 Lead

  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 was open to subjects that were previously enrolled in the original randomized Optimize RV Selective Site Pacing Clnical Trial (ORV)(NCT00422669) who consented between October 2009 through April 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two of 67 subjects were excluded due to non-compliant programming.

Reporting Groups
  Description
RV Apical Pacing

Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex

Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability

Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

RV Mid-Septal Pacing

Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart

Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability

Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead


Participant Flow:   Overall Study
    RV Apical Pacing     RV Mid-Septal Pacing  
STARTED     32     33  
COMPLETED     28     33  
NOT COMPLETED     4     0  
Physician Decision                 1                 0  
Lost to Follow-up                 1                 0  
Missing 24 month LVEF measurement                 2                 0  



  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
RV Apical Pacing

Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex

Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability

Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

RV Mid-Septal Pacing

Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart

Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability

Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Total Total of all reporting groups

Baseline Measures
    RV Apical Pacing     RV Mid-Septal Pacing     Total  
Number of Participants  
[units: participants]
  32     33     65  
Age  
[units: years]
Mean ± Standard Deviation
  75.6  ± 7.6     73.3  ± 10.6     74.4  ± 9.3  
Gender  
[units: participants]
     
Female     25     20     45  
Male     7     13     20  
Race (NIH/OMB)  
[units: subjects]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     3     5  
White     29     30     59  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month   [ Time Frame: 24 months ]

2.  Secondary:   Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.   [ Time Frame: 24 months ]

3.  Secondary:   Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.   [ Time Frame: 24 months ]

4.  Secondary:   Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.   [ Time Frame: Whole time from baseline to 24 months averaged by day ]


  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
Since the enrollment goal of the study (n=160) was not met (it was decided to stop enrollments after 67 due to slow enrollments), the results of the study were not powered and the results for the primary objective are inconclusive at this time.


  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 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.
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: Rachael Rose
Organization: Medtronic CRDM
phone: 763-526-2332
e-mail: rachael.k.rose@medtronic.com


No publications provided


Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00949715     History of Changes
Other Study ID Numbers: Optimize RV Follow-Up
Study First Received: July 28, 2009
Results First Received: March 11, 2013
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board
Italy: Medical Ethics Review Committee (METC)
Israel: Ethics Commission