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Prosthetic Valve

The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System) for Aortic Regurgitation (RIVAL - AR EFS Trial)

N/A
Waitlist Available
Led By Kendra Grubb, MD
Research Sponsored by HLT Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years following enrollment
Awards & highlights

RIVAL - AR EFS Trial Summary

This trial is testing a new valve to see if it is safe and effective in people who are at high risk for aortic valve replacement surgery.

RIVAL - AR EFS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years following enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years following enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mortality at 30 days
Secondary outcome measures
Adverse Events
Device Success- A composite endpoint per VARC-3, defined as meeting the following
Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo
+3 more

RIVAL - AR EFS Trial Design

1Treatment groups
Experimental Treatment
Group I: The HLT® Meridian® TAVR ValveExperimental Treatment1 Intervention
Transcatheter aortic valve replacement with the HLT Meridian TAVR Valve

Find a Location

Who is running the clinical trial?

HLT Inc.Lead Sponsor
5 Previous Clinical Trials
31 Total Patients Enrolled
Kendra Grubb, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
805 Total Patients Enrolled
Charles Davidson, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
1,196 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the expected total enrollment of participants in this clinical trial?

"Correct. Evidence collected from clinicaltrials.gov reveals that the endeavour, which was initially publicized on July 8th 2022, is actively seeking participants to be recruited at 3 seperate sites with a total of 10 spots available."

Answered by AI

Is this research endeavor still recruiting participants?

"The clinical trial is still open to applicants, as shown by the records on clinicaltrials.gov; this project was officially announced on July 8th 2022 with a most recent update occurring days after, on July 11th."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
2022. "HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05409378.
~0 spots leftby Apr 2025
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