Optimize RV Follow-up Selective Site Pacing Clinical Trial

Cardiac Pacing Clinical Trial

— ORVFUP  

Official title:

Optimize RV Follow-up Selective Site Pacing Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949715
• Other study ID #: Optimize RV Follow-Up
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: January 18, 2018
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Pacing
• Left Ventricular Ejection Fraction
• Right Ventricular Pacing

Intervention

Device:
• 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
• Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 months
Secondary	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.	24 months
Secondary	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.	Whole time from baseline to 24 months averaged by day