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The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

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ClinicalTrials.gov Identifier: NCT02536196
Recruitment Status : Completed
First Posted : August 31, 2015
Results First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Keystone Heart

Brief 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.

Condition or disease Intervention/treatment Phase
Symptomatic Aortic Stenosis Device: Embolic Protection Device Procedure: Transcatheter aortic valve implantation (TAVI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
Actual Study Start Date : June 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Embolic Protection with transcatheter aortic valve implantation (TAVI)
Device: Embolic Protection Device
Embolic protection

Procedure: Transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve implantation (TAVI)

Active Comparator: Control Arm
Transcatheter aortic valve implantation (TAVI) without embolic protection
Procedure: Transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve implantation (TAVI)

Primary Outcome Measures :
  1. Primary Safety Endpoint - Composite Safety Endpoint Based on MACCE [ Time Frame: 30 Days ]

    Combined safety endpoint at 30 days defined according to VARC-2 ("TAVI early safety") as a composite of:

    1. All-cause mortality - number of patients that expired
    2. All stroke (disabling and non-disabling) - defined by VARC-2 scale
    3. Life-threatening or disabled bleeding - BARC bleeding scale - 5 point scale ranging from no bleeding to fatal
    4. Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
    5. Coronary artery obstruction requiring intervention
    6. Major vascular complication, and
    7. Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) - number of patients in whom a valve related dysfunction occurred It was pre-specified to combine all participants that received the device in the andomized Intervention and Roll-in Arms/Groups for this Outcome Measure.

  2. Primary Efficacy Endpoint [ Time Frame: Pre-discharge through 30-days ]

    Hierarchical composite efficacy endpt, determined by pair-wise comparisons among subjects according to hierarchy:

    • mortality or any stroke [30 days]
    • death/stroke time to event analysis by days determine win
    • stroke at same day the comparison moves to next tier
    • NIHSS worsening [2-5 days post]
    • Freedom from lesions detected by DW-MRI 2-5 days post
    • Total volume lesions detected by DW-MRI 2-5 days post Each subj in intervention compared with each subj from control based on hierarchy according to Finkelstein-Schoenfeld method. If Subj A dies or has stroke &Subj B survives free of stroke to 30 days, Subj B wins(score+1) &Subj A loses (score-1). Both die or have stroke, patient with later event wins. Both have death/stroke on same day is equilibrium (score 0). Both are alive & have stroke on same day, comparison moves to next tier. Both stroke-free to 30 days, comparison moves to the next tier. Scores summed to cumulative score for each subj, &outcomes between groups are compared.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Subjects must meet ALL of the following criteria:

General Inclusion Criteria

  1. The patient is a male or non-pregnant female ≥18 years of age
  2. The patient meets indications for transcatheter aortic valve implantation (TAVI)
  3. The patient is willing to comply with protocol-specified follow-up evaluations
  4. The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Potential Subjects will be excluded if ANY of the following criteria apply:

General Exclusion Criteria

  1. Patients undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
  2. Patients undergoing transcatheter aortic valve implantation (TAVI) via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
  3. Patients with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve transcatheter aortic valve implantation (TAVI))
  4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 14 days prior to index procedure per site standard test
  5. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom Creatine Kinase (CK) and CK-MB have not returned to within normal limits at the time of procedure, or patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain
  6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months
  7. Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
  8. Patients with severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
  9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months
  10. Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
  11. Patients with hepatic failure (Child-Pugh class C)
  12. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
  13. Patients presenting with cardiogenic shock at the time of the index procedure
  14. Patients with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access
  15. Patients in whom the aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous
  16. Patients with an innominate artery ostium diameter <10 mm or >25 mm
  17. Patients with a transverse aortic diameter >43
  18. Patients with anatomic irregularities of the innominate artery that could prevent positioning of the TriGuard upper stabilizer and compromise stability of the device
  19. Patients with any other condition that would prevent adherence to the TriGuard HDH Instructions for Use
  20. Patients with contraindication to cerebral MRI
  21. Patients who have a planned treatment with any other investigational device or procedure during the study period
  22. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVI procedure or within 10 days prior to the TAVI procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 day prior to the TAVI procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536196

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Sponsors and Collaborators
Keystone Heart
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Principal Investigator: Alexandra J Lansky, MD alexandra.lansky@yale.edu
  Study Documents (Full-Text)

Documents provided by Keystone Heart:
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Responsible Party: Keystone Heart
ClinicalTrials.gov Identifier: NCT02536196    
Other Study ID Numbers: REFLECT
First Posted: August 31, 2015    Key Record Dates
Results First Posted: February 18, 2021
Last Update Posted: February 18, 2021
Last Verified: February 2021
Keywords provided by Keystone Heart:
Aortic stenosis
Keystone Heart
Cerebral Embolic Protection
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction