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Procedure
Tricuspid valve repair or replacement for Heart Failure (TVVAD Trial)
N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-operatively
Awards & highlights
TVVAD Trial Summary
This trial will help determine if tricuspid valve repair is beneficial for patients presenting with moderate or severe tricuspid regurgitation who are also having an LVAD implanted.
Eligible Conditions
- Heart Failure
- Tricuspid Regurgitation
TVVAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
TVVAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study armExperimental Treatment1 Intervention
Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy
Group II: Control armActive Control1 Intervention
LVAD implantation plus medical therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tricuspid valve repair or replacement
2018
N/A
~80
Find a Location
Who is running the clinical trial?
MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,165 Total Patients Enrolled
90 Trials studying Heart Failure
90,778 Patients Enrolled for Heart Failure
AbbottIndustry Sponsor
749 Previous Clinical Trials
477,413 Total Patients Enrolled
20 Trials studying Heart Failure
5,992 Patients Enrolled for Heart Failure
Duke UniversityLead Sponsor
2,357 Previous Clinical Trials
3,418,999 Total Patients Enrolled
63 Trials studying Heart Failure
46,446 Patients Enrolled for Heart Failure
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings to participate in this clinical research?
"According to the details available on clinicaltrials.gov, this trial is not currently enrolling subjects. Initially posted on August 22nd 2018 and last modified June 28th 2022, it appears that there are no recruitment needs at present. However, 739 other medical studies are actively searching for participants right now."
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