NCT00422669

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
6 countries

22 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

January 12, 2007

Results QC Date

June 9, 2011

Last Update Submit

January 24, 2013

Conditions

Cardiac Pacing, ArtificialCardiac Pacemaker, Artificial

Keywords

PacemakerImplantable Pulse Generator (IPG)AV Conduction DisturbanceSelect Site Pacing

Outcome Measures

Primary Outcomes (1)

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

    Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.

    Baseline and 24 months

Secondary Outcomes (5)

  • The Change in LVEF From Two Week Visit to Two Year Follow-up

    Baseline and 24 months

  • The Change in Six-minute Hall Walk Distance

    Baseline and 24 months

  • The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up

    Baseline and 24 months

  • Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up

    Baseline and 24 months

  • Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up

    Baseline and 24 months

Study Arms (2)

RV Mid-Septal Pacing

ACTIVE COMPARATOR

Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart

Device: Medtronic Dual-Chamber PacemakerDevice: Medtronic SelectSecure 3830 Lead

RV Apical Pacing

ACTIVE COMPARATOR

Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex

Device: Medtronic Dual-Chamber PacemakerDevice: Medtronic SelectSecure 3830 Lead

Interventions

Medtronic Dual-Chamber PacemakerDEVICE

A Medtronic market-approved dual-chamber implantable pulse generator (IPG)

RV Apical PacingRV Mid-Septal Pacing
Medtronic SelectSecure 3830 LeadDEVICE

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

RV Apical PacingRV Mid-Septal Pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Bridgeport, Connecticut, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Hudson, Florida, United States

Location

Unknown Facility

Des Moines, Iowa, United States

Location

Unknown Facility

Silver Spring, Maryland, United States

Location

Unknown Facility

Takoma Park, Maryland, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Tomball, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Montreal, Canada

Location

Unknown Facility

Hong Kong, China

Location

Unknown Facility

Ramat Gan, Israel

Location

Unknown Facility

Florence, Italy

Location

Unknown Facility

Rovigo, Italy

Location

Unknown Facility

Doha, Qatar

Location

Limitations and Caveats

Early study termination due to enrollment rates significantly below protocol expectations.

Results Point of Contact

Title
Optimize RV Trial Leader
Organization
Medtronic, Inc.
medtroniccrmtrials@medtronic.com
1-800-328-2518

Study Officials

  • Optimize RV Team

    Medtronic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 17, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

January 31, 2013

Results First Posted

November 1, 2012

Record last verified: 2013-01

Locations

CA(1)IT(2)US(16)CN(1)QA(1)IL(1)