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Trial record 22 of 228 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT03471065
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
Study of the Edwards Lifesciences SAPIEN 3 Ultra Valve and Delivery System in intermediate risk patients with severe, calcific, aortic stenosis requiring aortic valve replacement

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: TAVR Not Applicable

Detailed Description:
The procedural safety and procedural performance of the SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System in subjects with severe, calcific aortic stenosis who are at intermediate operative risk for standard aortic valve replacement (AVR) will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra Delivery System Used With the SAPIEN 3 Ultra THV and SAPIEN 3 THV in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
Patients will be implanted with the SAPIEN 3 Ultra THV using the SAPIEN 3 Ultra Delivery System
Device: TAVR
Implantation of the SAPIEN 3 Ultra THV using the SAPIEN 3 Ultra Delivery System




Primary Outcome Measures :
  1. Procedural success defined as freedom from mortality [ Time Frame: Day 0 ]
    End of procedure is defined as day 0


Secondary Outcome Measures :
  1. Number/percentage of patients who have a major vascular complication as per VARC II definition [ Time Frame: 3 days ]
    Discharge



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:

study:

  1. Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram (TTE) criteria: Aortic valve area (AVA) ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2 and jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
  2. New York Heart Association (NYHA) functional class ≥ II
  3. Judged by the Heart Team to be at intermediate risk for open surgical therapy
  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. Aortic valve is unicuspid, bicuspid or non-calcified
  2. Pre-existing mechanical or bioprosthetic valve in any position.
  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

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): NCT03471065


Contacts
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Contact: Tenley Koepnick 949-250-6504 Tenley_Koepnick@edwards.com

Locations
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Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec Recruiting
Québec City, Quebec, Canada
United Kingdom
Kings Hospital Recruiting
London, United Kingdom
St. Thomas Hospital Recruiting
London, United Kingdom
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: John Webb, MD St. Paul's Hospital

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03471065     History of Changes
Other Study ID Numbers: 2018-03
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available to other researchers.

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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
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Edwards Lifesciences:
Transcatheter
Transcatheter Valve Replacement
SAPIEN 3 Ultra

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction