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Optimize RV Selective Site Pacing Clinical Trial
This study has been terminated.
( Study enrollment significantly below protocol expectations )
First Received: January 12, 2007   Last Updated: June 8, 2009   History of Changes
Sponsor: Medtronic Cardiac Rhythm Disease Management
Information provided by: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00422669
  Purpose

The purpose of the Optimize RV 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 select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.


Condition Intervention
Cardiac Pacing, Artificial
Cardiac Pacemaker, Artificial
 Device: Medtronic Dual-Chamber Pacemaker
Device: Medtronic SelectSecure 3830 Lead

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title: Optimize RV Selective Site Pacing Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Pacemakers and Implantable Defibrillators
U.S. FDA Resources

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

Primary Outcome Measures:
  • Identify if Pacing at Selective RV Sites (Mid-Septum or Apex) Will Have a Different Impact on the Change in Left Ventricular Ejection Fraction (LVEF) After Two Years Follow up. [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Data collected to observe if Optimize RV pacing is superior to RVA pacing in high percentage ventricular paced (V-paced) subjects with normal to moderately impaired LV function. [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
RV Mid-Septal Pacing: Active Comparator
Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Device: Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Device: Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
RV Apical Pacing: Active Comparator
Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
Device: Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Device: Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

  Eligibility

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

Inclusion Criteria:

  • Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
  • Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
  • Subjects greater than 18 yrs of age
  • Subjects that are indicated for a dual chamber pacemaker
  • Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle

Exclusion Criteria:

  • Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
  • Subjects indicated for an implantable cardiac defibrillator (ICD)
  • Subjects with permanent atrial fibrillation (AF)
  • Subjects with expected managed ventricular pacing turned on
  • Subjects with a previously implanted pacemaker, ICD, or CRT device
  • Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
  • Subjects that received bypass surgery within 3 months prior to enrollment
  • Subjects that had valve replacement within 3 months prior to enrollment
  • Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
  • Subjects with a mechanical right heart valve
  • Women who are pregnant or nursing
  • Significant co-morbidity preventing study completion
  • Terminal conditions with a life expectancy of less than two years
  • Participation in another study that would confound the results of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422669

  Show 22 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Optimize RV Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic, Inc. ( Optimize RV Trial Leader )
Study ID Numbers: 604
Study First Received: January 12, 2007
Last Updated: June 8, 2009
ClinicalTrials.gov Identifier: NCT00422669     History of Changes
Health Authority: United States: Institutional Review Board;   Netherlands: Medical Ethics Review Committee (METC);   Canada: Ethics Review Committee;   Israel: Ethics Commission;   China: Ethics Committee;   China: State Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 08, 2010



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