Clinical Studies

Clinical Studies

REFLECT

Study Overview

REFLECT is a prospective, multi-center, single-arm, global study designed to demonstrate the safety and effectiveness of the TriGuard™ HDH (Phase I) & TriGUARD 3™ (Phase II) Cerebral Embolic Protection Devices during Transcatheter Aortic Valve Replacement (TAVR). To learn more, visit the study information page at www.ClinicalTrials.gov.

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Study Overview

ACC and EuroPCR Benefits of the TriGuard™ HDH Cerebral Embolic Protection Device During TAVR

Data presented at ACC (March 2015) and EuroPCR (May 2015) demonstrate benefits of Keystone Heart’s TriGuard™ HDH Cerebral Embolic Protection Device during TAVR. Based upon results from the DEFLECT III trial, the CE marked TriGuard™ HDH Cerebral Embolic Protection Device has improved in-hospital safety outcomes and cognitive scores at discharge during Transcatheter Aortic Valve Replacement (TAVR). Based on changes in NIH Stroke Scale, patients protected with the TriGuard™ HDH Cerebral Embolic Protection Device had 10% absolute reduction in stroke (4.9% vs. 14.3%). Minor strokes were under detected without detailed NIHSS assessment.

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Neuro-TAVI

Deflect III

Study Overview

Design:
  • Multicenter, prospective, single-blind, randomized controlled trial at 13 sites (EU/IL)
Objective:
  • To evaluate the safety, efficacy and performance of the TriGuard™ HDH Cerebral Embolic Protection Device protection compared with unprotected TAVR
  • Exploratory study with no formal hypothesis testing
Sample Size:
  • 86 patients selected to benchmark events for the design of a pivotal RCT
Conclusions
  • Use of the TriGuard™ HDH Cerebral Embolic Protection Device was safe and provided complete cerebral coverage in 87% of cases
  • Protection from the TriGuard™ HDH CEP device increased the proportion of patients completely free of ischemic brain lesions by more than 50% and reduced single and maximum lesion volume by about 40%
  • The TriGuard™ HDH Cerebral Embolic Protection Device appears to prevent cognitive decline and was associated with improved short-term and delayed memory at discharge compared to controls
  • Stroke was under-reported based on systematic NIHSS
  • Protected patients had a 10% absolute lower stroke rate
  • DEFLECT III provides proof of concept of the benefits of neuroprotection with the TriGuard™ HDH Cerebral Embolic Protection Device during TAVR and will benchmark event rates for a planned definitive randomized US-FDA IDE trial

Deflect II

Study Overview

OBJECTIVES:

This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™ HDH Cerebral Embolic Protection Device in patients undergoing TAVR.

BACKGROUND:

Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events.

METHODS:

This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI.

RESULTS:

Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™ HDH Cerebral Embolic Protection  device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049].

CONCLUSION:

This study showed the feasibility and safety of using the TriGuard™ HDH Cerebral Embolic Protection Device for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc.

Deflect I

Study Overview

Trial Design

DEFLECT I clinical data presented at PCR 2013 demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVR procedures using the TriGuard™ Embolic Deflection Device (EDD), compared with historical data on unprotected TAVR procedures.

Objectives:
  • To evaluate the safety and performance of the TriGuard™ Embolic Deflection Device in patients undergoing TAVR procedures
  • CE Marked submission on first 20 consecutive patients
Study Design:
  • Prospective, multi-center, single arm registry design
  • A minimum of 36 subjects up to a maximum of 60 to be enrolled at up to 10 centers in the European Union and Canada
Significant Lesion Volume Reduction
Significant Lesion Volume Reduction
Conclusions for DEFLECT-I Study
  • Use of the TriGuard™ Embolic Deflection Device is feasible and safe in patients undergoing TAVR
  • The TriGuard™ Embolic Deflection Device performed as intended in 82% of cases with full coverage of all 3 cerebral vessels until completion of TAVR deployment
  • There were no TriGuard™ Embolic Deflection Device related adverse events
  • Use of the TriGuard™ Embolic Deflection Device resulted in similar number of new lesions as historical controls
  • However, Average New Lesion Volume was smaller by 65% and the Total New Lesion Volume was 57% lower than historical controls
  • Further studies will further determine the role of the TriGuard™ Embolic Deflection Device in preventing ischemic brain injury during TAVR and other cardiac interventions

View various abstracts and manuscripts here.

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