Optimize RV Selective Site Pacing Clinical Trial

This study has been terminated.
(Study enrollment significantly below protocol expectations)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00422669
First received: January 12, 2007
Last updated: January 24, 2013
Last verified: January 2013
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimize RV Selective Site Pacing Clinical Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.


Secondary Outcome Measures:
  • The Change in LVEF From Two Week Visit to Two Year Follow-up [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.

  • The Change in Six-minute Hall Walk Distance [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.

  • The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).

  • Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.

  • Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.


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
Active Comparator: RV Mid-Septal Pacing
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
Active Comparator: RV Apical Pacing
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
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: 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 Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00422669     History of Changes
Other Study ID Numbers: 604
Study First Received: January 12, 2007
Results First Received: June 9, 2011
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)
Canada: Ethics Review Committee
Israel: Ethics Commission
China: Ethics Committee
China: 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 October 23, 2014