Tricuspid Regurgitation Study

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01093001

Collaborator

Abbott Medical Devices (Industry)

119

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation Right Ventricular Dysfunction Left Ventricular Dysfunction	Other: Echo Other: Echo Other: Echo Other: Echo	Phase 4

Detailed 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

Study Type:

Interventional

Actual Enrollment :

119 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lead size The pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr.	Other: Echo Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Active Comparator: RV Lead position 50 patients will be randomized to RV apex lead placement.	Other: Echo Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
Active Comparator: Mid-Septum Lead position 50 patients will be randomized to RV mid-septum lead placement.	Other: Echo Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Active Comparator: CS lead position 50 patients will have lead placed in the CS	Other: Echo Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. Other Names: Medtronic Starfix lead

Outcome Measures

Primary Outcome Measures

Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum. [12 months]

Secondary Outcome Measures

Left Ventricular lead placement will be associated with least amount of TR because of avoiding crossing the tricuspid valve and by virtue of relatively more synchronous ventricular contractions. [12 months]