Aortic StenosisNCT03003299

PARTNER 3 Trial - Aortic Valve-in-Valve

A study testing Edwards SAPIEN 3/SAPIEN 3 Ultra THV in people with Aortic Stenosis and Aortic Stenosis, Severe, run by Edwards Lifesciences at 51 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve. Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Stenosis, Aortic Stenosis, Severe
What is being tested?: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 51 sitesin 2 countries
Study dates: 5 Jan 2017to Apr 2038
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
NYHA Functional Class ≥ II.
Heart Team agrees the patient is low to intermediate risk.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Who cannot join

Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
Severe regurgitation (> 3+) or stenosis of any other valve
Failing valve has moderate or severe paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV

Show all 31Show fewer

Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
Anatomical characteristics that would preclude safe access to the apex (Transapical)
Evidence of an acute myocardial infarction ≤ 30 days before enrollment
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
Untreated clinically significant coronary artery disease requiring revascularization
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
Emergency interventional/surgical procedures within 30 days prior to the procedure
Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
Hypertrophic cardiomyopathy with obstruction
LVEF < 30%
Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
Stroke or transient ischemic attack within 90 days of enrollment
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
Renal insufficiency and/or renal replacement therapy at the time of screening
Active bacterial endocarditis within 180 days of the procedure
Patient refuses blood products
Estimated life expectancy < 24 months
Positive urine or serum pregnancy test in female subjects of childbearing potential
Currently participating in an investigational drug or another device study

Trial locations and contacts

51 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Edwards THV Clinical Affairs contact

(949) 250-2500

THV_CT.gov@Edwards.com

Country

City, postcode or hospital

Sites recruiting now only

51 sites in 2 countries

United States50 sites, 29 recruiting

Emory University Hospital
Atlanta, Georgia, 30322
Recruiting
JFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis, Florida, 33462
Withdrawn
Austin Heart, PLLC
Austin, Texas, 78756
Withdrawn
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Recruiting
University of Buffalo
Buffalo, New York, 14203
Withdrawn
Carolina's Health System
Charlotte, North Carolina, 28203
Withdrawn
University of Virginia
Charlottesville, Virginia, 22908
Withdrawn
Northwestern University Hospital
Chicago, Illinois, 60611
Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Recruiting
Medical City Dallas Hospital
Dallas, Texas, 75093
Recruiting
The Heart Hospital Baylor Plano
Dallas, Texas, 75093
Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Recruiting
Northshore University HealthSystem
Evanston, Illinois, 60201
Withdrawn
Inova Heart and vascular Instritute (Fairfax Inova)
Fairfax, Virginia, 22042
Withdrawn
University of Florida, Gainesville
Gainesville, Florida, 32610
Withdrawn
Hartford Hospital
Hartford, Connecticut, 06102
Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Recruiting
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111
Withdrawn
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Withdrawn
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Withdrawn
University of California Los Angeles
Los Angeles, California, 90095
Recruiting
UC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado, 80538
Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Withdrawn
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Withdrawn
Winthrop University Hospital
Mineola, New York, 11501
Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Withdrawn
Intermountain Medical Center
Murray, Utah, 84157
Recruiting
Saint Thomas Health Services
Nashville, Tennessee, 37205
Withdrawn
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Recruiting
New York University (NYU) Langone Medical Center
New York, New York, 10016
Withdrawn
Cornell University
New York, New York, 10021
Recruiting
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
Recruiting
Newark Beth Israel
Newark, New Jersey, 07112
Recruiting
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Recruiting
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Withdrawn
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Recruiting
Providence Heart & Vascular Institute
Portland, Oregon, 97225
Recruiting
NC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, 27607
Withdrawn
Mayo Clinic
Rochester, Minnesota, 55905
Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Withdrawn
Sutter Medical Center
Sacramento, California, 95919
Recruiting
Kaiser Permanente San Francisco
San Francisco, California, 94115
Withdrawn
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Withdrawn
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, 63110
Recruiting
Stanford University Medical Center
Stanford, California, 94305
Recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Recruiting

Other trials in United States

Canada1 site, 1 recruiting

St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, V6Z 1Y6
Recruiting

Other trials in Canada

About this study

Official title: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Read the detailed description

This is a prospective, single-arm, multicenter study.

Conditions: Aortic Stenosis, Aortic Stenosis, Severe
Being tested: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Keywords: SAPIEN 3, PARTNER 3, cardiovascular disease, heart disease, aortic stenosis, SAVR, TAVR, failing surgical valve, failing bioprosthetic valve, failing valve, SAPIEN 3 Ultra
Medical subject headings: Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Edwards SAPIEN 3/SAPIEN 3 Ultra THVDevice
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Study groups in NCT03003299
Study group	Role	What they receive
TAVR - Failing surgical or transcatheter valve	Experimental	Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR). Receives: Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Number of patients that died and/or had a stroke
Measured: 1 year

Secondary outcomes (5)

Mean gradient
Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
Measured: 30 days
Peak gradient
Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
Measured: 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
Measured: 30 days
New York Heart Association (NYHA) Classification
Change from baseline in NYHA. NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Measured: 30 days
Six-Minute Walk Test (6MWT)
Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 2017Apr 2038

First posted28 Dec 2016 (estimated)
Study start5 Jan 2017
Primary completionJan 2033 (estimated)
Study completionApr 2038 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic StenosisStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 125 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03003299
Sponsor's protocol ID: 2015-08 AVIV
Status last verified: May 2024
First submitted: 19 Dec 2016
Last updated: 10 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

Edwards THV Clinical Affairs

(949) 250-2500

THV_CT.gov@Edwards.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
ClinicalTrials.gov ID: NCT03003299
Acronym / sponsor ID: 2015-08 AVIV
Conditions: Aortic Stenosis, Aortic Stenosis, Severe
Keywords: SAPIEN 3, PARTNER 3, cardiovascular disease, heart disease, aortic stenosis, SAVR, TAVR, failing surgical valve
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 125 participants (estimated)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 5 Jan 2017 (actual)
Primary completion: Jan 2033 (estimated)
Study completion: Apr 2038 (estimated)
First posted: 28 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Detailed description

This is a prospective, single-arm, multicenter study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAVR - Failing surgical or transcatheter valve	Experimental	Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THVPatients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
NYHA Functional Class ≥ II.
Heart Team agrees the patient is low to intermediate risk.
Heart Team agrees valve implantation will likely benefit the patient.

Key exclusion criteria (31 listed)

Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
Severe regurgitation (> 3+) or stenosis of any other valve
Failing valve has moderate or severe paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Edwards SAPIEN 3/SAPIEN 3 Ultra THVEdwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.	Device	TAVR - Failing surgical or transcatheter valve

Primary outcome

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Time frame: 1 year
Number of patients that died and/or had a stroke

5 secondary outcomes

Mean gradient
Time frame: 30 days
Peak gradient
Time frame: 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 30 days
New York Heart Association (NYHA) Classification
Time frame: 30 days
Six-Minute Walk Test (6MWT)
Time frame: 30 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Edwards THV Clinical Affairs contact

(949) 250-2500

THV_CT.gov@Edwards.com

Chris S Malaisrie, MD principal investigator

Northwestern University

Alan Zajarias, MD principal investigator

Washington University School of Medicine

Mayra Guerrero, MD principal investigator

Mayo Clinic

51 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Edwards SAPIEN 3/SAPIEN 3 Ultra THV in people with Aortic Stenosis and Aortic Stenosis, Severe, run by Edwards Lifesciences at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edwards THV Clinical Affairs ((949) 250-2500, THV_CT.gov@Edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03003299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.