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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

July 28, 2009
July 23, 2013
September 2009
April 2011   (final data collection date for primary outcome measure)
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
Change in mean Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00949715 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Optimize RV Follow-up Selective Site Pacing Clinical Trial
Optimize RV Follow-up Selective Site Pacing Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cardiac Pacing
  • Right Ventricular Pacing
  • LVEF >/=40%
  • 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 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
    Interventions:
    • Device: Medtronic or Vitatron Dual-Chamber Pacemaker
    • Device: Medtronic SelectSecure 3830 Lead
  • Active Comparator: RV Apical Pacing
    Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
    Interventions:
    • Device: Medtronic or Vitatron Dual-Chamber Pacemaker
    • Device: Medtronic SelectSecure 3830 Lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel,   Italy
 
NCT00949715
Optimize RV Follow-Up
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: Optimize RV Follow-Up Team Medtronic
Medtronic Cardiac Rhythm Disease Management
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP