Tricuspid Regurgitation Study

Left Ventricular Dysfunction Clinical Trial

Official title:

The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093001
• Other study ID #: 08-008690
• 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

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• Right Ventricular Dysfunction
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Dysfunction, Right

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

External Links

•   Mayo Clinic Clinical Trials