DEFLECT I: Keystone Heart Embolic Deflection Trial

NCT01448421 | Completed Results DMC

• 1 other identifier: DEFLECT I
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR). The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve. The new valve is put into place using a long, thin tube called a catheter that is inserted into a small incision (cut) in the patient's groin and threaded through his/her arteries up to the heart.

Conditions

Aortic Stenosis

Keywords

TAVR

Outcome Measures

Primary Outcomes (2)

• Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance)

  Device ability to access and deploy in the aortic arch and position the device to cover all three vessels.

  During the procedure

• Number of Serious Adverse Events Related to Investigational Device and Procedure

  Incidence of investigational device- and investigational procedure-related serious adverse events

  30 days follow-up

Study Arms (1)

Keystone Heart Embolic Deflection Device

EXPERIMENTAL

Protected Transcatheter Aortic Valve Replacement

Device: Keystone Heart Embolic Deflection Device

Interventions

Keystone Heart Embolic Deflection Device DEVICE

The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.

Keystone Heart Embolic Deflection Device

Eligibility Criteria

• Age: 18 Years - 80 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.
• Patient meets indications for TAVR procedure.
• 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 or Institutional Review Board.

You may not qualify if:

• Patients undergoing TAVR 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, in whom creatine kinase and creatine kinase 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 impaired renal function (estimated Glomerular Filtration Rate \[estimated Glomerular Filtration Rate\] \<30, calculated from serum creatinine by the Cockcroft-Gault formula)
• Patients with a platelet count of \<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 who will refuse transfusion.
• Patients who have received any organ transplant or are on a waiting list for any organ transplant.
• 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 known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, 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 presenting with cardiogenic shock.
• Patients with severe peripheral arterial disease that precludes 9 French sheath vascular access.
• Patients with documented friable or mobile atherosclerotic plaque in the aortic arch.

Sponsors & Collaborators

• Keystone Heart: lead

Related Publications (1)

• Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention. 2015 May;11(1):75-84. doi: 10.4244/EIJY15M04_01.

  PMID: 25868876 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Karen Jaffe, VP RA./QA/CA
• Organization: keystoneheart

karen.jaffe@keystoneheart.com

97246158005

Study Officials

• Michael Mullen, Md.

  The Heart Hospital, London, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 7, 2011
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 14, 2020
• Results First Posted: September 14, 2020

Record last verified: 2014-01