Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement (ExCEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517436
Recruitment Status : Active, not recruiting
First Posted : May 7, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To establish the safety and effectiveness of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR)

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Transcatheter Aortic Valve Replacement (TAVR) Not Applicable

Detailed Description:
A prospective, single-arm, controlled, multicenter study. Additional subjects may be enrolled in a bicuspid registry.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Edwards CENTERA THV Device: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with the Edwards CENTERA THV System and accessories
Other Names:
  • TAVR
  • TAVI




Primary Outcome Measures :
  1. Non-hierarchical composite endpoint of all-cause death and/or stroke [ Time Frame: 1-year ]
    Units of Death and Stroke are both measured as count



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe, calcific AS meeting the following transthoracic echocardiogram (TTE) criteria: AV area ≤ 1.0 cm2 OR AV area index ≤ 0.6 cm2/m2, Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
  2. NYHA functional class ≥ II
  3. Judged by the Heart Team to be at intermediate risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% and < 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator)
  4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

  1. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion).
  2. Known hypersensitivity to Nitinol (nickel or titanium)
  3. Severe aortic regurgitation (> 3+)
  4. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
  5. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
  6. Stroke or transient ischemic attack within 90 days of the valve implant procedure
  7. Severe lung disease or currently on home oxygen
  8. Severe pulmonary hypertension
  9. History of cirrhosis or any active liver disease

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): NCT03517436


  Show 23 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Layout table for investigator information
Principal Investigator: Martin Leon, MD Columbia University Medical Center/ NYPH

Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03517436     History of Changes
Other Study ID Numbers: 2017-18
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Edwards Lifesciences:
THV
Transcatheter Heart Valve
CENTERA
self-expanding
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction