Tricuspid Regurgitation Study
Primary Purpose
Tricuspid Regurgitation, Right Ventricular Dysfunction, Left Ventricular Dysfunction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Echo
Echo
Echo
Echo
Sponsored by
About this trial
This is an interventional prevention trial for Tricuspid Regurgitation focused on measuring Reduce Tricuspid Regurgitation, Reduce Right Ventricular pacing, Lead position, Lead size
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Lead size
RV Lead position
Mid-Septum Lead position
CS lead position
Arm Description
The pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr.
50 patients will be randomized to RV apex lead placement.
50 patients will be randomized to RV mid-septum lead placement.
50 patients will have lead placed in the CS
Outcomes
Primary Outcome Measures
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01093001
First Posted
March 24, 2010
Last Updated
November 2, 2016
Sponsor
Mayo Clinic
Collaborators
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01093001
Brief Title
Tricuspid Regurgitation Study
Official Title
The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Right Ventricular Dysfunction, Left Ventricular Dysfunction
Keywords
Reduce Tricuspid Regurgitation, Reduce Right Ventricular pacing, Lead position, Lead size
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lead size
Arm Type
Active Comparator
Arm Description
The pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr.
Arm Title
RV Lead position
Arm Type
Active Comparator
Arm Description
50 patients will be randomized to RV apex lead placement.
Arm Title
Mid-Septum Lead position
Arm Type
Active Comparator
Arm Description
50 patients will be randomized to RV mid-septum lead placement.
Arm Title
CS lead position
Arm Type
Active Comparator
Arm Description
50 patients will have lead placed in the CS
Intervention Type
Other
Intervention Name(s)
Echo
Intervention Description
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Intervention Type
Other
Intervention Name(s)
Echo
Intervention Description
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
Intervention Type
Other
Intervention Name(s)
Echo
Intervention Description
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Intervention Type
Other
Intervention Name(s)
Echo
Other Intervention Name(s)
Medtronic Starfix lead
Intervention Description
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Primary Outcome Measure Information:
Title
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Mei Cha, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
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Tricuspid Regurgitation Study
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