Optimize RV Follow-up Selective Site Pacing Clinical Trial (ORVFUP)

Medtronic

Status: Completed

Conditions: Cardiac Pacing; Left Ventricular Ejection Fraction; Right Ventricular Pacing

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949715

Optimize RV Follow-Up

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

RV Mid-Septal Pacing

Active Comparator group

Description:

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

Treatment:

Device: Medtronic SelectSecure 3830 Lead

Device: Medtronic or Vitatron Dual-Chamber Pacemaker

RV Apical Pacing

Active Comparator group

Description:

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

Treatment:

Device: Medtronic SelectSecure 3830 Lead

Device: Medtronic or Vitatron Dual-Chamber Pacemaker