Circulating Biomarkers of Hypo-Attenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement

Who is this study for? Patients with severe native AS or severe bioprosthetic valve degeneration undergoing transfemoral TAVR
What treatments are being studied? Proteomics Analysis
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: No
View:

• Age > 65 years

• Subject with severe native AS or severe bioprosthetic valve degeneration

• Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve

Locations
United States
Massachusetts
Massachusetts General Hospital
Recruiting
Boston
Minnesota
Minneapolis Heart Institute
Not yet recruiting
Minneapolis
New Hampshire
Catholic Medical Center
Recruiting
Manchester
Contact Information
Primary
Roukoz Abou Karam
raboukaram@mgh.harvard.edu
Backup
Paris J Jamiel, BS
pjamiel@mgh.harvard.edu
(617) 726-0996
Time Frame
Start Date: June 22, 2020
Estimated Completion Date: June 22, 2035
Participants
Target number of participants: 300
Treatments
Other: HALT Cohort
Patients who develop HALT
Other: Control Group
Patients who do not develop HALT
Sponsors
Collaborators: Minneapolis Heart Institute, Medtronic, Catholic Medical Center
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials