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DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI (TAVI)

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ClinicalTrials.gov Identifier: NCT02070731
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Keystone Heart

Study Description
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Brief Summary:
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: TriGuard HDH Not Applicable

Detailed Description:

The TriGuard HDH device 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.

To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI.

Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms:

  • Intervention - TAVI with the TriGuard HDH embolic deflection device
  • Control - standard unprotected TAVI

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: unprotected TAVI
standard unprotected Transcatheter Aortic Valve Implantation
Experimental: TAVI with the TriGuard HDH
TAVI with the TriGuard HDH embolic deflection device
 Device: TriGuard HDH
TAVI with the TriGuard HDH embolic deflection device
Other Name: TriGuard HDH embolic deflection device


Outcome Measures
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Primary Outcome Measures :
  1. In hospital procedural safety [ Time Frame: Up to 7 days during post procedure hospitalization ]

    In-hospital procedural safety, defined as the composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE):

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life threatening (or disabling) bleeding
    • Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
    • Major vascular complications


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

Inclusion Criteria:

  • The patient is a male or non-pregnant female ≥18 years of age
  • Patient meets indications for TAVI
  • The patient is willing to comply with protocol-specified follow-up evaluations
  • 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 Medical Ethics Committee (EC) or Institutional Review Board (IRB)

Exclusion Criteria:

  • Patients undergoing TAVI via the trans-axillary, trans-subclavian, or trans-aortic route
  • Patients undergoing TAVI via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
  • 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 7 days prior to index procedure per site standard test
  • 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 and creatine kinase-Muscle Brain have not returned to within normal limits at the time of procedure.
  • Patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain
  • Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
  • Patients with known other 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
  • Patients with severe allergy to heparin or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
  • Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • Patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months
  • Patients with renal failure (estimated Glomerular Filtration Rate [estimated Glomerular Filtration Rate] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
  • Patients with hepatic failure (Child-Pugh class C)
  • Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
  • Patients presenting with cardiogenic shock or severe hypotension (systolic blood pressure <90 mm Hg) at the time of the index procedure
  • Patients with severe peripheral arterial disease that precludes delivery sheath vascular access
  • Patients with a heavily calcified or severely atheromatous aortic arch
  • Patients with an innominate artery ostium diameter <11 mm
  • Patients with a transverse aortic diameter >40 mm
  • Patients with anatomic irregularities of the aortic arch or innominate artery that could prevent positioning and stability of the device
  • Patients with contraindication to cerebral MRI
  • Patients who have a planned treatment with any other investigational device or procedure during the study period
  • Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVI procedure or within two (2) weeks prior to the TAVI procedure.
Contacts and Locations
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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): NCT02070731


Locations
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France
Hôpital de la Cavale Blanche
Brest, France
Chru-Lille
Lille, France, 59000
Clinique chez APHM
Marseille, France
Germany
Praxisklinik Herz Und Gefässe
Dresden, Germany
Universitäts-Herzzentrum Freiburg
Freiburg, Germany
Medical Care Center
Hamburg, Germany
Städtische Kliniken Neuss
Neuss, Germany
Israel
Rambam Medical Center
Haifa, Israel
Shaarey Tzedek
Jerusalem, Israel
Italy
Ferrarotto hospital
Catania, Italy
Netherlands
UMC Utrecht
Utrecht, Netherlands
United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Heart Institute
Bristol, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Sponsors and Collaborators
Keystone Heart
Investigators
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Principal Investigator: Andreas Baumbach, Md. Bristol Heart Institute
More Information
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Responsible Party: Keystone Heart
ClinicalTrials.gov Identifier: NCT02070731     History of Changes
Other Study ID Numbers: DEFLECT III
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Keystone Heart:
TAVR
TAVI
Aortic Valve Stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction