Tricuspid Regurgitation Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
| End Date: | May 2016 |
The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation
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.
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.
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.
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.
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
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