Trials Sponsors Conditions Drugs Pricing

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

SAPIEN 3TransfemoralTransapicalTransaorticTAVIAortic StenosisTHVAortic ValveTranscatheter Heart ValveTAVR

Outcome Measures

Primary Outcomes (1)

The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate
The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
30 Days

Secondary Outcomes (2)

Number of Participants With Major Vascular Complications
30 Days
Number of Participants With Aortic Insufficiency at 30 Days
30 Days

Study Arms (1)

SAPIEN 3™ valve

EXPERIMENTAL

Device: TAVR Implantation of the THV Prosthesis

Interventions

TAVR Implantation of the THV ProsthesisDevice

Patients with TAVR implantation

Also known as: SAPIEN 3™valve

SAPIEN 3™ valve

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.

Sponsors & Collaborators

Edwards Lifesciences
Industrylead

Study Sites (40)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Mercy General Hospital

Sacramento, California, 95819, United States

Stanford University Medical Center

Stanford, California, 94305, United States

University of Colorado Hospital

Denver, Colorado, 80045, United States

Washington Hospital Center DC

Washington D.C., District of Columbia, 20010, United States

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Emory University

Atlanta, Georgia, 30322, United States

Related Publications (4)

Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e007948. doi: 10.1161/CIRCOUTCOMES.121.007948. Epub 2022 Jan 18.
PMID: 35041482DERIVED
Ong G, Pibarot P, Redfors B, Weissman NJ, Jaber WA, Makkar RR, Lerakis S, Gopal D, Khalique O, Kodali SK, Thourani VH, Anwaruddin S, McAndrew T, Zhang Y, Alu MC, Douglas PS, Hahn RT. Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry. J Am Coll Cardiol. 2020 Dec 22;76(25):2940-2951. doi: 10.1016/j.jacc.2020.10.032.
PMID: 33334422DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title: Edwards THV Clinical Affairs
Organization: Edwards Lifesciences

Study Officials

Martin B Leon, MD
Columbia University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

583 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

October 2013

Actual (reported)

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

SAPIEN 3™ valve

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (40)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

SAPIEN 3™ valve

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (40)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations