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Tricuspid Regurgitation Study

This study has been completed.
St. Jude Medical
Information provided by (Responsible Party):
Yong-Mei Cha, Mayo Clinic Identifier:
First received: March 24, 2010
Last updated: November 2, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Tricuspid Regurgitation
Right Ventricular Dysfunction
Left Ventricular Dysfunction
Other: Echo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum. [ Time Frame: 12 months ]

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. [ Time Frame: 12 months ]

Enrollment: 119
Study Start Date: May 2010
Study Completion Date: May 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lead size
The pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr.
Other: Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Active Comparator: RV Lead position
50 patients will be randomized to RV apex lead placement.
Other: Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
Active Comparator: Mid-Septum Lead position
50 patients will be randomized to RV mid-septum lead placement.
Other: Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Active Comparator: CS lead position
50 patients will have lead placed in the CS
Other: Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Other Name: Medtronic Starfix lead

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01093001

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
St. Jude Medical
Principal Investigator: Yong-Mei Cha, MD Mayo Clinic
  More Information

Additional Information:
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.

Responsible Party: Yong-Mei Cha, Cardiovascular Division, Mayo Clinic Identifier: NCT01093001     History of Changes
Other Study ID Numbers: 08-008690
Study First Received: March 24, 2010
Last Updated: November 2, 2016

Keywords provided by Mayo Clinic:
Reduce Tricuspid Regurgitation
Reduce Right Ventricular pacing
Lead position
Lead size

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Ventricular Dysfunction, Right
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases processed this record on April 26, 2017