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Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population

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: NCT03466918
Recruitment Status : Active, not recruiting
First Posted : March 15, 2018
Results First Posted : July 15, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Symptomatic Aortic Stenosis Aortic Regurgitation Device: SAPIEN 3 THV with the Commander delivery system Not Applicable

Detailed Description:

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.

A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : July 3, 2019
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with SAPIEN 3 THV
Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system
Device: SAPIEN 3 THV with the Commander delivery system
Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system




Primary Outcome Measures :
  1. All-cause Mortality [ Time Frame: 30-days ]
    All of the deaths that occurred in this population regardless of the cause.


Secondary Outcome Measures :
  1. Cardiovascular Mortality [ Time Frame: 30-days ]
    All of the deaths that occurred in this population due to a cardiovascular issue.

  2. Non-Cardiovascular Mortality [ Time Frame: 30-days ]
    All of the deaths that occurred in this population due to a non-cardiovascular issue.

  3. Number of Participants With a Stroke [ Time Frame: 30-days ]
    Total number of participates with a stroke.



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.
  2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.
  3. NYHA Functional Class II or greater.
  4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.
  5. The study patient agrees to comply with all required postprocedure follow-up visits.

Exclusion Criteria:

  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
  2. Aortic valve is a congenital unicuspid or is non-calcified.
  3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).
  4. Anomalous coronary artery that would interfere with proper placement of the valve.
  5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

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): NCT03466918


Locations
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China
Fuwai Hospital, CAMS&PUMC
Beijing, China
WestChina Hospital, Sichuan University
Chengdu, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhongshan Hospital Fudan University
Shanghai, China
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Prof Junbo GE Zhongshan Hospital and Fudan University
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03466918    
Other Study ID Numbers: 2017-08
First Posted: March 15, 2018    Key Record Dates
Results First Posted: July 15, 2020
Last Update Posted: September 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
TAVI
TAVR
CHINA
SAPIEN 3
High Risk
Transcatheter aortic valve implantation
Transcatheter aortic valve replacement
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction