Tricuspid Regurgitation Study

Phase 4

Completed

• Conditions: Right Ventricular Dysfunction; Tricuspid Regurgitation; Left Ventricular Dysfunction
• Interventions: Other: Echo

• Registration Number: NCT01093001
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Study Start: 2010-05
• Primary Completion: 2015-09
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• 18 years of either sex

  • Patient is recommended to receive a pacemaker or an ICD
  • Provide informed consent

Read More

Exclusion Criteria

• Pregnant or breastfeeding women
• Congenital heart disease
• Pre-existing moderate or severe TR
• An existing pacemaker or defibrillator
• Pulmonary hypertension
• Pacemaker dependence
• Unable to give informed consent
• Not feasible for patient to be followed up at Mayo Clinic
• Acute myocardial infarction within 7 days

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lead size	Echo	The pacemaker lead will be \< or = to 7Fr. The ICD lead will be 9 Fr.
CS lead position	Echo	50 patients will have lead placed in the CS
RV Lead position	Echo	50 patients will be randomized to RV apex lead placement.
Mid-Septum Lead position	Echo	50 patients will be randomized to RV mid-septum lead placement.

Primary Outcome Measures

Name	Time	Method
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States