Tricuspid Regurgitation Study
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
119 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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