Optimize RV Follow-up Selective Site Pacing Clinical Trial

Medtronic Cardiac Rhythm and Heart Failure67 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cardiac Pacing Right Ventricular Pacing Left Ventricular Ejection Fraction

Interventions

Medtronic or Vitatron Dual-Chamber PacemakerDEVICE

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

Medtronic SelectSecure 3830 LeadDEVICE

Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Unnamed facility

Des Moines, Iowa, United States

Unnamed facility

Silver Spring, Maryland, United States

Unnamed facility

Southfield, Michigan, United States

Unnamed facility

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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.

Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.

Time frame: 24 months

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

Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.

Time frame: 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.

Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.

Time frame: Whole time from baseline to 24 months averaged by day

Data from ClinicalTrials.gov

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