Optimize RV Follow-up Selective Site Pacing Clinical Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Pacing Right Ventricular Pacing Left Ventricular Ejection Fraction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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RV Mid-Septal Pacing

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

Group Type ACTIVE_COMPARATOR

Medtronic or Vitatron Dual-Chamber Pacemaker

Intervention Type DEVICE

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

Medtronic SelectSecure 3830 Lead

Intervention Type DEVICE

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

RV Apical Pacing

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

Group Type ACTIVE_COMPARATOR

Medtronic or Vitatron Dual-Chamber Pacemaker

Intervention Type DEVICE

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

Medtronic SelectSecure 3830 Lead

Intervention Type DEVICE

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Interventions

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Medtronic or Vitatron Dual-Chamber Pacemaker

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

Intervention Type DEVICE

Medtronic SelectSecure 3830 Lead

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No