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
  Purpose

The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of selective site pacing is to improve how the heart contracts when paced.


Condition Intervention
Cardiac Pacing
Right Ventricular Pacing
LVEF >/=40%
Device: Medtronic or Vitatron Dual-Chamber Pacemaker
Device: Medtronic SelectSecure 3830 Lead

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Optimize RV Follow-up Selective Site Pacing Clinical Trial

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.

  • Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.

  • 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 ] [ Designated as safety issue: No ]
    Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.


Enrollment: 67
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Device: 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
Device: Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
Active Comparator: RV Apical Pacing
Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Device: 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
Device: Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Detailed Description:

The Optimize RV Follow-Up Selective Site Pacing Clinical Trial is open to subjects that were previously enrolled in the Optimize RV Selective Site Pacing Clinical Trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects enrolled in the Optimize RV study (version 3, dated 6 March 2007)
  • Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)

Exclusion Criteria:

  • Subjects who have a device that was programmed outside the Optimize RV programming requirements
  • Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
  • Subjects who are pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949715

Locations
United States, Iowa
Des Moines, Iowa, United States
United States, Maryland
Silver Spring, Maryland, United States
United States, Michigan
Southfield, Michigan, United States
United States, Minnesota
Saint Paul, Minnesota, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
Tomball, Texas, United States
United States, Vermont
Burlington, Vermont, United States
Israel
Ramat Gan, Israel
Italy
Rovigo, Italy
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Optimize RV Follow-Up Team Medtronic
  More Information

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

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Pacemaker
Implantable Pulse Generator (IPG)
AV Conduction Disturbance
Selective Site Pacing

ClinicalTrials.gov processed this record on August 21, 2014