NCT01093001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

5.3 years

First QC Date

March 24, 2010

Last Update Submit

November 2, 2016

Conditions

Tricuspid RegurgitationRight Ventricular DysfunctionLeft Ventricular Dysfunction

Keywords

Reduce Tricuspid RegurgitationReduce Right Ventricular pacingLead positionLead size

Outcome Measures

Primary Outcomes (1)

  • Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.

    12 months

Secondary Outcomes (1)

  • 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

Study Arms (4)

Lead size

ACTIVE COMPARATOR

The pacemaker lead will be \< or = to 7Fr. The ICD lead will be 9 Fr.

Other: Echo

RV Lead position

ACTIVE COMPARATOR

50 patients will be randomized to RV apex lead placement.

Other: Echo

Mid-Septum Lead position

ACTIVE COMPARATOR

50 patients will be randomized to RV mid-septum lead placement.

Other: Echo

CS lead position

ACTIVE COMPARATOR

50 patients will have lead placed in the CS

Other: Echo

Interventions

EchoOTHER

Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.

Lead size

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of either sex
  • Patient is recommended to receive a pacemaker or an ICD
  • Provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyVentricular Dysfunction, RightVentricular Dysfunction, Left

Interventions

Caves

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction

Intervention Hierarchy (Ancestors)

Geological PhenomenaPhysical PhenomenaEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Yong-Mei Cha, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Division

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2015

Study Completion

May 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

US(1)