Tricuspid Regurgitation Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 08-008690
NCT ID: NCT01093001
Sponsor Protocol Number: 08-008690
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Study closed to enrollment
Inclusion Criteria:
- At least 18 years of age 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yongmei Cha, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available