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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead size | Active Comparator | The pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr. |
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| RV Lead position | Active Comparator | 50 patients will be randomized to RV apex lead placement. |
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| Mid-Septum Lead position | Active Comparator | 50 patients will be randomized to RV mid-septum lead placement. |
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| CS lead position | Active Comparator | 50 patients will have lead placed in the CS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echo | Other | Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum. | 12 months |
| 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 |
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Inclusion Criteria:
18 years of either sex
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Mei Cha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Lin G, Nishimura R, Connolly H, Dearani J, Sundt T, Hayes D: Severe symptomatic tricuspid valve regurgitation due to permanent pacemaker or implantable cardioverter-defibrillator leads. JACC 2005; 45:1672-1675. 2. Leibowitz D, Rosenheck S, Pollak A, Geist M, Gilon D: Transvenous pacemaker leads do not worsen tricuspid regurgitation: a prospective echocardiographic study. Arrhythmias, Electrophysiology and Electrocardiography 2000; 93:74-77. 3. Kucukarslan N, Kirilmaz A, Ulusoy E, Yokusoglu M, Gramatnikovski N, Ozal E, Tatar H: Tricuspid insufficiency does not increase early after permanent implantation of pacemaker leads. J Card Surg 2006; 21:391-394. 4. Wilkoff B, Invesigators DT: The dual chamber and WI implantable defibrillator (DAVID) Trial: rationale, design, results, clinical implications and lessons for future trials. Cardiac Electrophysiol Review 2004; 7:468-472. |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D018497 | Ventricular Dysfunction, Right |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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| ID | Term |
|---|---|
| D059552 | Caves |
| ID | Term |
|---|---|
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
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| Echo | Other | Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation |
|
| Echo | Other | Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. |
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| Echo | Other | Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. |
|
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| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |