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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01093001
Other study ID # 08-008690
Secondary ID
Status Completed
Phase Phase 4
First received March 24, 2010
Last updated November 2, 2016
Start date May 2010
Est. completion date May 2016

Study information

Verified date November 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date May 2016
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
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.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic St. Jude Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum. 12 months No
Secondary 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 No
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