Tricuspid Regurgitation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation

Conditions
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Tricuspid Regurgitation, Right Ventricular Dysfunction, Left Ventricular Dysfunction

Intervention / Treatment
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* Other: Echo
* Other: Echo
* Other: Echo
* Other: Echo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of either sex Patient is recommended to receive a pacemaker or an ICD Provide informed consent 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduce Tricuspid Regurgitation, Reduce Right Ventricular pacing, Lead position, Lead size