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

NCT02070731 | Completed DMC

• 1 other identifier: DEFLECT III
• Study Type: interventional
• Target: 86
• Locations: 6 countries
• Sites: 14

Brief Summary

A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.

Conditions

Aortic Valve Stenosis

Keywords

TAVR; TAVI; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• In hospital procedural safety

  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

  Up to 7 days during post procedure hospitalization

Study Arms (2)

unprotected TAVI

NO INTERVENTION

standard unprotected Transcatheter Aortic Valve Implantation

TAVI with the TriGuard HDH

EXPERIMENTAL

TAVI with the TriGuard HDH embolic deflection device

Device: TriGuard HDH

Interventions

TriGuard HDH DEVICE

TAVI with the TriGuard HDH embolic deflection device

Also known as: TriGuard HDH embolic deflection device

TAVI with the TriGuard HDH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Keystone Heart: lead

Study Sites (14)

Hôpital de la Cavale Blanche

Brest, France

Location

Chru-Lille

Lille, 59000, France

Location

Clinique chez APHM

Marseille, France

Location

Praxisklinik Herz Und Gefässe

Dresden, Germany

Location

Universitäts-Herzzentrum Freiburg

Freiburg im Breisgau, Germany

Location

Medical Care Center

Hamburg, Germany

Location

Städtische Kliniken Neuss

Neuss, Germany

Location

Rambam Medical Center

Haifa, Israel

Location

Shaarey Tzedek

Jerusalem, Israel

Location

Ferrarotto hospital

Catania, Italy

Location

UMC Utrecht

Utrecht, Netherlands

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Bristol Heart Institute

Bristol, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Andreas Baumbach, Md.

  Bristol Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

FR (3); DE (4); IL (2); IT (1); NL (1); GB (3)