Optimize RV Selective Site Pacing Clinical Trial
Information source: Medtronic Cardiac Rhythm Disease Management
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Pacing, Artificial; Cardiac Pacemaker, Artificial
Intervention: Implantable Pulse Generator (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Medtronic Cardiac Rhythm Disease Management Official(s) and/or principal investigator(s):
Optimize RV Team, Study Chair, Affiliation: Medtronic
Overall contact:
Optimize RV Team, Email: medtroniccrmtrials@medtronic.com
Summary
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.
Clinical Details
Official title: Optimize RV Selective Site Pacing Clinical Trial
Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Primary outcome: 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.
Secondary outcome: Data collected to observe if Optimize RV (mid-septal) pacing is superior to RVA pacing in high % Vpaced subjects with normal to moderately impaired LV function.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects that are expected to be RV paced >90% of the time
- Subjects with EF >40% within 3 months prior to enrollment
- Subjects >18yrs 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) (based on ACC/AHA/HRS
guidelines)
- Subjects indicated for an implantable cardiac defibrillator (ICD)
- Subjects with permanent atrial fibrillation (AF)
- Subjects with expected managed ventricular pacing (MVP) turned on
- Subjects with a previously implanted pacemaker or ICD, CRT
- Subjects with an myocardial infarction (MI) within 3 months 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
Locations and Contacts
Optimize RV Team, Email: medtroniccrmtrials@medtronic.com
Montreal, Canada; Recruiting
Hong Kong, China; Not yet recruiting
Ramat Gan, Israel; Recruiting
Firenze, Italy; Recruiting
Rovigo, Italy; Recruiting
Maastricht, Netherlands; Not yet recruiting
Dordrecht, Netherlands; Not yet recruiting
Doha, Qatar; Not yet recruiting
Belgrade, Serbia; Withdrawn
Little Rock, Arkansas, United States; Withdrawn
Palo Alto, California, United States; Recruiting
Bridgeport, Connecticut, United States; Recruiting
Clearwater, Florida, United States; Recruiting
Hudson, Florida, United States; Recruiting
Atlanta, Georgia, United States; Withdrawn
Indianapolis, Indiana, United States; Withdrawn
Des Moines, Iowa, United States; Recruiting
Silver Spring, Maryland, United States; Recruiting
Takoma Park, Maryland, United States; Recruiting
Southfield, Michigan, United States; Recruiting
Saint Paul, Minnesota, United States; Recruiting
Jackson, Mississippi, United States; Withdrawn
Omaha, Nebraska, United States; Recruiting
Cary, North Carolina, United States; Withdrawn
Cincinnati, Ohio, United States; Withdrawn
Cleveland, Ohio, United States; Recruiting
Salem, Oregon, United States; Withdrawn
Nashville, Tennessee, United States; Recruiting
Fort Worth, Texas, United States; Recruiting
Dallas, Texas, United States; Recruiting
Tomball, Texas, United States; Recruiting
Salt Lake City, Utah, United States; Recruiting
Burlington, Vermont, United States; Recruiting
Additional Information
Starting date: January 2007
Ending date: June 2012
Last updated: June 26, 2008
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