Study Summary
This trial is testing a new system for aortic valve replacement in people who are at high risk for the surgery. The goal is to see if it is safe and works well.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Throughout the 5 year follow up period
Trial Safety
Trial Design
1 Treatment Group
HLT Transcatheter Aortic Valve System
1 of 1
Experimental Treatment
35 Total Participants · 1 Treatment Group
Primary Treatment: HLT Transcatheter Aortic Valve System · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 65+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Rodés-Cabau, Josep, Mathew R. Williams, Harindra C. Wijeysundera, Dean J. Kereiakes, Jean-Michel Paradis, Cezar Staniloae, Muhamed Saric, Sam Radhakrishnan, Robert F. Wilson, and Spencer H. Kubo. 2019. “Transcatheter Aortic Valve Replacement with the HLT Meridian Valve”. Circulation: Cardiovascular Interventions. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circinterventions.119.008053.
- Rodés-Cabau, Josep, Mathew R. Williams, Harindra C. Wijeysundera, Dean J. Kereiakes, Jean-Michel Paradis, Cezar Staniloae, Muhamed Saric, Sam Radhakrishnan, Robert F. Wilson, and Spencer H. Kubo. 2019. “Transcatheter Aortic Valve Replacement with the HLT Meridian Valve”. Circulation: Cardiovascular Interventions. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circinterventions.119.008053.
- Rodes-Cabau J, Williams MR, Wijeysundera HC, Kereiakes DJ, Paradis JM, Staniloae C, Saric M, Radhakrishnan S, Wilson RF, Kubo SH. Transcatheter Aortic Valve Replacement With the HLT Meridian Valve. Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31.
- 2017. "Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02799823.
Frequently Asked Questions
Are participants still being enrolled for this research study?
"As per the clinicaltrials.gov registry, this clinical trial is actively seeking subjects for testing. The listing of this medical experiment was first posted on April 27th 2017 and modified most recently on June 29th 2022." - Anonymous Online Contributor
How many healthcare facilities have initiated this research experiment?
"The Lindner Center for Research and Education at the Christ Hospital in Cincinnati, Ohio, Baylor Scott & White The Heart Hospital Plano in Plano, Texas, and NYU Langone Medical Center are among the multiple clinical trial sites running this medical study. Other 4 participating locations have also been identified." - Anonymous Online Contributor
How many participants are currently undergoing treatment in this clinical experiment?
"Correct. Clinicaltrials.gov confirms that this clinical study, which was first uploaded on April 27th 2017, is actively looking for participants. Approximately 35 patients across 4 different sites need to be enrolled in the trial." - Anonymous Online Contributor