DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR

NCT02073851 | Completed

• 1 other identifier: DEFLECT II
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.

Conditions

Aortic Valve Stenosis

Keywords

TAVR

Outcome Measures

Primary Outcomes (1)

• Device performance

  Device performance will be evaluated for the following functions: Access the aortic arch, Deploy the TriGuard™HDH from the delivery catheter, Position the TriGuard™HDH to cover the cerebral/carotid vessels, Retrieve the TriGuard™HDH system intact

  During TAVR procedure

Secondary Outcomes (2)

• Number of new cerebral lesions

  one week post procedure

• Volume of new cerebral lesions

  One week post procedure

Study Arms (1)

TriGuard™HDH

EXPERIMENTAL

Patients undergoing TAVR will be treated wIth experimental device TriGuard™HDH

Device: TriGuard™HDH

Interventions

TriGuard™HDH DEVICE

TriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

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 must be ≥ 18 years of age.
• The patient meets indications for transcatheter aortic valve replacement procedure.
• The patient is willing to comply with 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 been provided written informed consent, approved by the appropriate Medical Ethics Committee (EC).

You may not qualify if:

• Patients undergoing transcatheter aortic valve replacement via the trans-axillary, subclavian, or direct aortic route
• 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 and creatine kinase and creatine kinase fraction have not returned to 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 impaired renal function (estimated Glomerular Filtration Rate \[Estimated Glomerular Filtration Rate\] \<30, calculated from serum creatinine by the Cockcroft-Gault formula).
• Patients with torturous/unsuitable anatomy as related to major cerebral arteries in the aortic arch that may interfere with device deployment or remain deployed.
• Patients with a platelet count \<100.000 cells/mm³ or \>700.000 cells/mm³ or a white blood cell \<3000 cells/mm³ within 7 days prior to index procedure.
• Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or will refuse transfusion.
• Patients who have received any organ transplant or are on a waiting list for any organ transplant.
• Poor fluoroscopic visualization due to obesity or other medical reason
• Hypotension requiring iv/ia medication or other therapy such as resuscitation and defibrillation
• Patients with known other medical 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 a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, latex, 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 upper gastrointestinal (GI) bleeding within the prior 6 months.

Sponsors & Collaborators

• Keystone Heart: lead

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

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

• Pieter Stella, Md.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 27, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

NL (1)