Clinical trial NCT00422669: Optimize RV Selective Site Pacing Clinical Trial
Official title: Optimize RV Selective Site Pacing Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Pacing, Artificial
Cardiac Pacemaker, Artificial
Keywords: Pacemaker
Implantable Pulse Generator (IPG)
AV Conduction Disturbance
Select Site Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: The Change in LVEF From Two Week Visit to Two Year Follow-up
timeFrame: Baseline and 24 months
measure: The Change in Six-minute Hall Walk Distance
timeFrame: Baseline and 24 months
measure: The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up
timeFrame: Baseline and 24 months
measure: Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up
timeFrame: Baseline and 24 months
measure: Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up
timeFrame: Baseline and 24 months
Other outcomes:
Locations:
city: Bridgeport
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Hudson
country: United States
state: Florida
city: Des Moines
country: United States
state: Iowa
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Southfield
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Cleveland
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Montreal
country: Canada
city: Hong Kong
country: China
city: Ramat Gan
country: Israel
city: Firenze
country: Italy
city: Rovigo
country: Italy
city: Doha
country: Qatar
Study officials:
affiliation: Medtronic
name: Optimize RV Team
role: STUDY_CHAIR
References: