- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02070731
DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI (TAVI)
A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brest, France
- Hôpital de la cavale blanche
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Lille, France, 59000
- Chru-Lille
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Marseille, France
- Clinique chez APHM
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Dresden, Germany
- Praxisklinik Herz und Gefäße
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Freiburg, Germany
- Universitats-Herzzentrum Freiburg
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Hamburg, Germany
- Medical Care Center
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Neuss, Germany
- Städtische Kliniken Neuss
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Haifa, Israel
- Rambam Medical Center
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Jerusalem, Israel
- Shaarey Tzedek
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Catania, Italy
- Ferrarotto Hospital
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Utrecht, Netherlands
- UMC Utrecht
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Brighton, United Kingdom
- Royal Sussex County Hospital
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Bristol, United Kingdom
- Bristol Heart Institute
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Leeds, United Kingdom
- Leeds General Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: unprotected TAVI
standard unprotected Transcatheter Aortic Valve Implantation
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EXPERIMENTAL: TAVI with the TriGuard HDH
TAVI with the TriGuard HDH embolic deflection device
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TAVI with the TriGuard HDH embolic deflection device
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In hospital procedural safety
Time Frame: Up to 7 days during post procedure hospitalization
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In-hospital procedural safety, defined as the composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE):
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Up to 7 days during post procedure hospitalization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreas Baumbach, Md., Bristol Heart Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEFLECT III
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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