Optimize RV Follow-up Selective Site Pacing Clinical Trial

NCT00949715 | Completed Results

• 1 other identifier: Optimize RV Follow-Up
• Study Type: interventional
• Target: 67
• Locations: 3 countries
• Sites: 12

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.

Conditions

Cardiac Pacing; Right Ventricular Pacing; Left Ventricular Ejection Fraction

Keywords

Pacemaker; Implantable Pulse Generator (IPG); AV Conduction Disturbance; Selective Site Pacing

Outcome Measures

Primary Outcomes (1)

• Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month

  Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view

  24 months

Secondary Outcomes (3)

• 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.

  24 months

• Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.

  24 months

• Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.

  Whole time from baseline to 24 months averaged by day

Study Arms (2)

RV Mid-Septal Pacing

ACTIVE COMPARATOR

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

Device: Medtronic or Vitatron Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead

RV Apical Pacing

ACTIVE COMPARATOR

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

Device: Medtronic or Vitatron Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead

Interventions

Medtronic or Vitatron Dual-Chamber Pacemaker DEVICE

A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability

RV Apical Pacing; RV Mid-Septal Pacing

Medtronic SelectSecure 3830 Lead DEVICE

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

RV Apical Pacing; RV Mid-Septal Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (12)

Unknown Facility

Des Moines, Iowa, United States

Location

Unknown Facility

Silver Spring, Maryland, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Tomball, Texas, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Ramat Gan, Israel

Location

Unknown Facility

Rovigo, Italy

Location

Limitations and Caveats

Since the enrollment goal of the study (n=160) was not met (it was decided to stop enrollments after 67 due to slow enrollments), the results of the study were not powered and the results for the primary objective are inconclusive at this time.

Results Point of Contact

• Title: Rachael Rose
• Organization: Medtronic CRDM

rachael.k.rose@medtronic.com

763-526-2332

Study Officials

• Optimize RV Follow-Up Team

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 30, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 15, 2018
• Results First Posted: October 1, 2013

Record last verified: 2018-01

Locations

US (10); IL (1); IT (1)