Clinical trial NCT01093001: Tricuspid Regurgitation Study
Official title: The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tricuspid Regurgitation
Right Ventricular Dysfunction
Left Ventricular Dysfunction
Keywords: Reduce Tricuspid Regurgitation
Reduce Right Ventricular pacing
Lead position
Lead size
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2010-03-25
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yong-Mei Cha, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.