Tricuspid Regurgitation Study

Completed · Phase 4

Conditions studied: Tricuspid Regurgitation, Right Ventricular Dysfunction, Left Ventricular Dysfunction

In brief

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.

Key facts

Study ID

NCT01093001

Run by

Mayo Clinic

People needed

119

Starts

2010-05-01

Expected to finish

2016-05-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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