Tricuspid Regurgitation Study

November 2, 2016 updated by: Yong-Mei Cha, Mayo Clinic

The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • Medtronic Starfix lead
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.
Other Names:
  • Medtronic Starfix lead
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.
Other Names:
  • Medtronic Starfix lead
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 Names:
  • Medtronic Starfix lead
Other: Echo
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Yong-Mei Cha, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-008690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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