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

NCT03471065 | Completed Results FDA Device

• 1 other identifier: 2018-03
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 6

Brief Summary

This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter; Transcatheter Valve Replacement; SAPIEN 3 Ultra

Outcome Measures

Primary Outcomes (1)

• Procedural Success

  The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation

  Day 0

Secondary Outcomes (2)

• Major Vascular Complications

  Discharge, expected to be within 1-5 days post-procedure]

• Valve Migration or Embolization

  Discharge, expected to be within 1-5 days post-procedure]

Study Arms (1)

Transcatheter Aortic Valve Replacement (TAVR)

EXPERIMENTAL

Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV

Interventions

SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV DEVICE

Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.

Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
• Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2
• Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
• New York Heart Association functional class ≥ II
• Judged by the Heart Team to be at intermediate risk for open surgical therapy
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

• Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
• Aortic valve is unicuspid, bicuspid or non-calcified
• Pre-existing mechanical or bioprosthetic valve in any position.
• Severe aortic regurgitation (\> 3+)
• Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis
• Ventricular dysfunction with left ventricular ejection fraction \< 30%
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
• Subjects with planned concomitant ablation for atrial fibrillation
• Hypertrophic cardiomyopathy with obstruction
• Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
• Complex coronary artery disease:
• Unprotected left main coronary artery
• SYNTAX score \> 32
• Heart Team assessment that optimal revascularization cannot be performed

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (6)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Location

Kings Hospital

London, United Kingdom

Location

St. Thomas Hospital

London, United Kingdom

Location

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: Edwards THV Clinical Affairs
• Organization: Edwards Lifesciences

THV_CT.gov@edwards.com

949-250-2500

Study Officials

• John Webb, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

• Bernard Prendergast, Prof

  St. Thomas Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: SAPIEN 3 Ultra System

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 20, 2018
• Study Start: June 1, 2018
• Primary Completion: December 23, 2019
• Study Completion: January 21, 2025
• Last Updated: May 18, 2025
• Results First Posted: January 19, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); GB (2)