Tricuspid Regurgitation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Yong-Mei Cha, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01093001
First received: March 24, 2010
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01093001

Contacts
Contact: Celeste M Koestler, RN 507-255-2200 koestler.celeste@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Celeste M Koestler, RN    507-255-2200    koestler.celeste@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
St. Jude Medical
Investigators
Principal Investigator: Yong-Mei Cha, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Yong-Mei Cha, Cardiovascular Division, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093001     History of Changes
Other Study ID Numbers: 08-008690
Study First Received: March 24, 2010
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014