Tricuspid Regurgitation Study

Left Ventricular Dysfunction Clinical Trial

Official title: The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation

Status Completed

Clinical Trial Summary

The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex.

Clinical Trial Description

Leads are commonly placed in the right ventricular apex. It is not known whether placing similar leads higher on the septum where there will be less redundancy or pressure on the septal leaflet will change the extent and severity of tricuspid regurgitation following pacemaker/ICD implantation. Data has shown that right ventricular pacing can give rise to right ventricular dysfunction, which in turn may give rise to enlargement of the right ventricle and cause tricuspid regurgitation.

The study will answer the clinically relevant questions on device lead-related tricuspid regurgitation.

This study is a single center prospective study at the Mayo Clinic, Rochester. The study will enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing via coronary sinus 50 ICD subjects will be enrolled with right ventricular apex pacing.

A baseline heart failure assessment and Two Dimensional echocardiography will be performed before device implant.

A Two Dimensional echo will be performed 24 hours after device implant. If significance TR is present a Three Dimensional echo will be performed. At 12 months post implant heart failure assessment and Two Dimensional echo will be performed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• Right Ventricular Dysfunction
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Dysfunction, Right

• NCT number: NCT01093001
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 4
• Start date: May 2010
• Completion date: May 2016