Optimize RV Follow-up Selective Site Pacing Clinical Trial
This study is enrolling participants by invitation only.
Sponsor:
Medtronic Cardiac Rhythm Disease Management
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00949715
First received: July 28, 2009
Last updated: August 13, 2010
Last verified: August 2010
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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, Artificial Cardiac Pacemaker, Artificial |
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 |
Resource links provided by NLM:
Further study details as provided by Medtronic Cardiac Rhythm Disease Management:
Primary Outcome Measures:
- Change in mean Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 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
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: | Optimize RV Follow-Up Trial Leader, Medtronic, Inc. |
| ClinicalTrials.gov Identifier: | NCT00949715 History of Changes |
| Other Study ID Numbers: | Optimize RV Follow-Up |
| Study First Received: | July 28, 2009 |
| Last Updated: | August 13, 2010 |
| 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 May 19, 2013