TerminatedNot Applicable

Optimize RV Selective Site Pacing Clinical Trial

Stopped: Study enrollment significantly below protocol expectations

United States, Canada, China205 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 st…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up

Timeframe: Baseline and 24 months

Trial details

NCT IDNCT00422669

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-05

Results submitted2011-06-09

View on ClinicalTrials.gov More Cardiac Pacing, Artificial trials