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

Brief Title

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

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

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)

Detailed Description

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

Study Type

Interventional

Primary Outcome

Non-hierarchical composite endpoint of all-cause death and/or stroke

Condition

Aortic Valve Stenosis

Intervention

TAVR with CENTERA THV

Study Arms / Comparison Groups

 Transcatheter Aortic Valve Replacement (TAVR)

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

September 18, 2018

Completion Date

July 2030

Primary Completion Date

October 2, 2020

Eligibility 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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Martin Leon, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03517436

Organization ID

2017-18

Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences

Study Sponsor

Martin Leon, MD, Principal Investigator, Columbia University Medical Center/ NYPH

Verification Date

October 2020