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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 : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Keystone Heart

August 26, 2015
August 31, 2015
January 17, 2019
June 2016
June 2019   (Final data collection date for primary outcome measure)
  • Primary Safety Endpoint [ 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
    2. All stroke (disabling and non-disabling)
    3. Life-threatening or disabled bleeding
    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)
  • Primary Efficacy Endpoint [ Time Frame: Pre-discharge through 30-days ]
    Hierarchical composite efficacy endpoint, determined by pair-wise comparisons among all subjects according to the following pre-specified hierarchy of adverse outcomes:
    1. All-cause mortality or any stroke (disabling or non-disabling) [evaluated at 30 days]
    2. NIHSS worsening (increase from baseline) or Montreal Cognitive Assessment worsening (decrease from baseline) [evaluated at post-procedure/pre-discharge]
    3. Total volume of cerebral ischemic lesions detected by diffusion-weighted magnetic resonance imaging (DW-MRI) 2 to 5 days post-procedure
Total volume of cerebral ischemic lesions detected by diffusion-weighted magnetic resonance imaging (DW-MRI) [ Time Frame: 2 to 5 days post-procedure ]
Complete list of historical versions of study NCT02536196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
In-hospital Procedural Safety [ Time Frame: 30 Days post-procedure ]
In-hospital procedural safety, defined as the composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE): 1) coronary artery obstruction requiring intervention, 2) major vascular complication, and 3) valve-related dysfunction requiring repeat procedure
 
The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Symptomatic Aortic Stenosis
  • Device: Embolic Protection Device
    Embolic protection
  • Procedure: Transcatheter aortic valve implantation (TAVI)
    Transcatheter aortic valve implantation (TAVI)
  • Experimental: Intervention
    Embolic Protection with transcatheter aortic valve implantation (TAVI)
    Interventions:
    • Device: Embolic Protection Device
    • Procedure: Transcatheter aortic valve implantation (TAVI)
  • Active Comparator: Control Arm
    Transcatheter aortic valve implantation (TAVI) without embolic protection
    Intervention: Procedure: Transcatheter aortic valve implantation (TAVI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
285
Same as current
August 2019
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Alexandra J Lansky, MD (203) 737-2142 alexandra.lansky@yale.edu
Germany,   Italy,   Netherlands,   United States
Israel,   United Kingdom
 
NCT02536196
REFLECT
No
Not Provided
Not Provided
Keystone Heart
Keystone Heart
Not Provided
Principal Investigator: Alexandra J Lansky, MD alexandra.lansky@yale.edu
Keystone Heart
January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP