Clinical Trials Logo

Clinical Trial Summary

The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.


Clinical Trial Description

This prospective, single-blind, three arm, randomized, (2 device: 1 control), multicenter safety and efficacy trial is designed to enroll up to 603 total subjects in two consecutive phases: Phase I enrolled 258 subjects (including 54 Roll-Ins) and utilized the TriGuard HDH and Phase II will enroll up to 345 subjects (including 40-50 Roll-Ins) and will utilize the TriGUARD 3 (Figure 3b shows the patient flow/disposition). Phase I In phase I, a total of 204 evaluable subjects and 54 roll-in subjects were enrolled at 26 total investigational sites in the United States, Europe, and Israel, of which 20 sites were in the United States. A minimum of 50% of subjects were planned to be enrolled at US sites, and no single site was permitted to enroll more than 20% of all subjects. Subjects with indications for TAVI and who met study eligibility criteria were randomized 2:1 (stratified by study site) to one of two treatment arms: - Intervention (Phase 1 Cohort) - TAVI with the TriGuard HDH CEPD - Control - standard unprotected TAVI At sites where the investigator did not have prior experience with the TriGuard device (minimum of 2 prior cases), up to 3 roll-in subjects were enrolled. Roll-in subjects were not randomized, but underwent TAVI with the TriGuard HDH device. These cases were proctored by a Sponsor representative. Investigational sites with ≥2 prior TriGuard cases were allowed to enroll 1 roll-in subject at the discretion of the site principal investigator. All subjects were to be followed clinically in-hospital and at 30 and 90 days, and to undergo diffusion-weighted MR imaging 2 to 5 days post-procedure, and neurologic and neuropsychological testing pre-procedure, post-procedure (2-5 days post-procedure), and at 30 and 90 days. The initial randomized cohort expected to enroll up to 285 subjects. Note: Enrollment in Phase I has been halted after enrolling a total of 258 subjects (54 roll-ins and 204 randomized subjects including 63 controls) based on the recommendation of the Data Monitoring Committee following a review of interim 30-day data on 90 subjects at the prespecified interim analysis time point. A next iteration device designed for increased efficacy, ease of use, and improved safety will be tested in Phase II (below). Phase II In Phase II, up to 295 randomized subjects and 40-50 roll-in subjects will be enrolled at up to 25 sites in the United States (inclusive of sites enrolling subjects in Phase I). No single site will be permitted to enroll more than 20% of all randomized subjects in Phase II. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 (stratified by study site) to one of two treatment arms: - Intervention - TAVI with the TriGUARD 3 CEPD - Control - standard unprotected TAVI. Randomization will be stratified by implanted valve type (Medtronic vs. Edwards). No single valve type will be implanted in more than approximately 70% of randomized patients (phase II). Roll-in subjects (a minimum of 2 and a maximum of 3 Roll-ins per-site) will not be randomized, but will undergo TAVI with the TriGUARD 3 device. These cases will be proctored by a Sponsor representative. All subjects will be followed clinically in-hospital and at 30 days, undergo diffusion-weighted MR imaging 2 to 5 days post-procedure, and undergo neurologic (NIHSS) testing pre-procedure, post-procedure (2-5 days post-procedure), and at 30 days. A follow-up phone-call to assess the occurrence of death or stroke will be done at 90 days. The initial randomized cohort will consist of up to 225 subjects. After at least 50% of the initial randomized cohort (approximately 112 subjects) have reached the 30 day primary efficacy endpoint evaluation time point, a sample size reestimation will be performed in case the conditional power of the trial (assessed by the independent biostatistician) is >40% but <80%, subject to approval by the Sponsor. If this analysis determines that more than 225 randomized subjects will be required to ensure adequate study power, enrollment may continue until the required number of subjects have been enrolled, or until the total subject limit for the study has been reached (whichever occurs first). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02536196
Study type Interventional
Source Keystone Heart
Contact
Status Completed
Phase N/A
Start date June 2016
Completion date June 2019

See also
  Status Clinical Trial Phase
Completed NCT03003650 - ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort N/A
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Active, not recruiting NCT04091048 - Optimize PRO Study
Withdrawn NCT03247465 - Image Fusion and Calcification Raising in Trans Aortic Valve Implantation N/A
Completed NCT03143686 - ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Active, not recruiting NCT05182307 - DurAVR™ THV System: First-In-Human Study N/A
Active, not recruiting NCT03466918 - China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population N/A
Completed NCT01819181 - Women's INternational Transcatheter Aortic Valve Implantation Registry
Completed NCT04331145 - Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation Phase 4
Recruiting NCT02803294 - Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population Phase 4
Recruiting NCT04861805 - Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System N/A
Withdrawn NCT02088021 - Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access N/A
Terminated NCT02759237 - The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS) N/A
Recruiting NCT01794832 - Severe Aortic Stenosis in Patients Referred for Valve Surgery N/A
Completed NCT02424370 - Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation
Completed NCT01493284 - Portico TAVI Implant With Transfemoral Delivery System N/A
Active, not recruiting NCT05712161 - Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study N/A
Completed NCT02664649 - Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis Phase 3
Completed NCT01487330 - First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System N/A
Active, not recruiting NCT04722250 - SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial N/A