Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
119 participants
INTERVENTIONAL
2010-05-31
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lead size
The pacemaker lead will be \< or = to 7Fr. The ICD lead will be 9 Fr.
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
RV Lead position
50 patients will be randomized to RV apex lead placement.
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
Mid-Septum Lead position
50 patients will be randomized to RV mid-septum lead placement.
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
CS lead position
50 patients will have lead placed in the CS
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Interventions
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Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is recommended to receive a pacemaker or an ICD
* Provide informed consent
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Yong-Mei Cha
Cardiovascular Division
Principal Investigators
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Yong-Mei Cha, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
Other Identifiers
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08-008690
Identifier Type: -
Identifier Source: org_study_id