Optimize RV Selective Site Pacing Clinical Trial

Stopped early · Not applicable

Conditions studied: Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial

In brief

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.

Key facts

Study ID

NCT00422669

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

205

Starts

2007-01-01

Expected to finish

2009-05-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Bridgeport, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Hudson, Florida, United States
• Study site — Des Moines, Iowa, United States
• Study site — Silver Spring, Maryland, United States
• Study site — Takoma Park, Maryland, United States
• Study site — Southfield, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Cleveland, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Tomball, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Burlington, Vermont, United States
• Study site — Montreal, Canada
• Study site — Hong Kong, China
• Study site — Ramat Gan, Israel
• Study site — Florence, Italy
• Study site — Rovigo, Italy
• Study site — Doha, Qatar

Full record on ClinicalTrials.gov

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