Clinical trial NCT00949715: Optimize RV Follow-up Selective Site Pacing Clinical Trial
Official title: Optimize RV Follow-up Selective Site Pacing Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacing
Right Ventricular Pacing
Left Ventricular Ejection Fraction
Keywords: Pacemaker
Implantable Pulse Generator (IPG)
AV Conduction Disturbance
Selective Site Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month
timeFrame: 24 months
Secondary outcomes:
measure: Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.
timeFrame: 24 months
measure: Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.
timeFrame: 24 months
measure: Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.
timeFrame: Whole time from baseline to 24 months averaged by day
Other outcomes:
Locations:
city: Des Moines
country: United States
state: Iowa
city: Silver Spring
country: United States
state: Maryland
city: Southfield
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Ramat Gan
country: Israel
city: Rovigo
country: Italy
Study officials:
affiliation: Medtronic
name: Optimize RV Follow-Up Team
role: STUDY_CHAIR
References: