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Aortic StenosisPII S3i CAPNCT02687035

PARTNER II Trial: S3iCAP

A study testing SAPIEN S3 valve in people with Aortic Stenosis, run by Edwards Lifesciences at 56 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk. Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Stenosis
What is being tested?
SAPIEN S3 valve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,822 participants
Where
56 sitesin 2 countries
Study dates
Jan 2015to Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted.
  • Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors.
  • 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.
  • Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI).
  • Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  • The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
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  • Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present).
  • 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 Institutional Review Board (IRB) of the respective clinical site.
  • The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

Who cannot join

  • Heart team assessment of inoperability (including examining cardiac surgeon).
  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  • Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation >3+).
  • Pre-existing mechanical or bioprosthetic valve in any position.
  • Complex coronary artery disease:
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  • Unprotected left main coronary artery
  • Syntax score > 32 (in the absence of prior revascularization)
  • Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
  • Any patient with a balloon valvuloplasty (BAV) < 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
  • Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
  • Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL).
  • Hypertrophic cardiomyopathy with or without obstruction (HOCM).
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
  • Need for emergency surgery for any reason.
  • Severe ventricular dysfunction with LVEF < 20%.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Active upper GI bleeding within 3 months (90 days) prior to procedure.
  • A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  • Native aortic annulus size < 16 mm or > 28mm as measured by echocardiogram.
  • Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
  • Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
  • Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal dis-ease or chronic end stage pulmonary disease.
  • Expectation that patient will not improve despite treatment of aortic stenosis.
  • Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
  • Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F introducer sheath such as severe obstructive calcification, severe tortuosity or min-imum average vessel size less than 5.5 mm. (Transfem-oral).
  • Currently participating in an investigational drug or an-other device study. Note: Trials requiring extended fol-low-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  • Active bacterial endocarditis within 6 months (180 days) of procedure.
  • Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.
  • Inability to tolerate anticoagulation/antiplatelet therapy.
  • For transfemoral approach only: Femoro-iliac vessels < 5.5 mm for the 23 mm and the 26 mm system and < 6.0 mm for the 29 mm system.

Trial locations and contacts

56 sites in 2 countries.

56 sites in 2 countries

United States55 sites

  • University of Michigan Hospital and Health Systems

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Austin Heart, PLLC

    Austin, Texas, 78756

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21201

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina Charleston

    Charleston, North Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22904

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • University of Colorado Hospital

    Denver, Colorado, 80045

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27712

  • NorthShore University HealthSystem Research Institute

    Evanston, Illinois, 60201

  • University of Florida

    Gainesville, Florida, 32615

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University Health-Methodist Hospital

    Indianapolis, Indiana, 46202

  • St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC

    Indianapolis, Indiana, 46290

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Saint Luke's Hospital of Kansas City Mid America

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92307

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville Jewish Hospital

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • Winthrop-University Hospital

    Mineola, New York, 11501

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Cornell University

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Northshore Long Island Jewish Health System

    New York, New York, 10075

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • Stanford Hospital and Clinics

    Palo Alto, California, 94305

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225

  • Mayo Clinic-Saint Marys Hospital

    Rochester, Minnesota, 55905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Mercy General Hospital

    Sacramento, California, 95816

  • Intermountain Medical Center

    Salt Lake City, Utah, 84157

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University of Washington

    Seattle, Washington, 98195

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • Washington University/ Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington Hospital Center DC

    Washington D.C., District of Columbia, 20010

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Canada1 site

  • St. Paul's Hospital, Providence Health Care

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)

Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.

Read the detailed description

This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.

Conditions
Aortic Stenosis
Being tested
SAPIEN S3 valve
Keywords
S3iCAP, SAPIEN 3, Transfemoral, Commander, Certitude, TAVR, TAVI, Aortic stenosis, THV, Transcatheter Heart Valve, TVT, TVTR
Medical subject headings
Aortic Valve Stenosis

What participants receive

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

  • SAPIEN S3 valveDevice

    Also called TAVR, TAVI, Transcatheter aortic valve replacement, SAPIEN

    Transcatheter aortic valve replacement

Study groups in NCT02687035
Study groupRoleWhat they receive
TAVRExperimentalIntermediate risk patients receiving transcatheter aortic valve replacement (TAVR)
Receives: Device: SAPIEN S3 valve

What is being measured

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

  1. Death

    Number of deaths

    Measured: 30 days

  2. Death

    Number of deaths

    Measured: 1 year

  3. Stroke

    Number of participants with stroke

    Measured: 30 days

  4. Stroke

    Number of participants with stroke

    Measured: 1 year

  5. Aortic Valve Reintervention

    Number of participants with aortic valve reintervention

    Measured: 30 days

  6. Aortic Valve Reintervention

    Number of participants with aortic valve reintervention

    Measured: 1 year

Secondary outcomes (8)

  1. Annular Dissection

    Number of participants with annular dissection

    Measured: 30 days

  2. Aortic Dissection

    Number of participants with aortic dissection

    Measured: 30 days

  3. Major Access Vascular Site Complication

    Number of participants with major vascular complications

    Measured: 30 days

  4. Unplanned Vascular Surgery or Intervention

    Number of participants with unplanned vascular surgery or intervention

    Measured: 30 days

  5. Retroperitoneal Bleeds

    Number of participants with retroperitoneal bleed

    Measured: 30 days

  6. Gastrointestinal Bleed

    Number of participants with gastrointestinal bleeding

    Measured: 30 days

  7. Genitourinary Bleed

    Number of participants with genitourinary bleeding

    Measured: 30 days

  8. Bleeding at Access Site

    Number of participants with bleeding at the access site

    Measured: 30 days

Timeline

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

  1. First posted22 Feb 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2017
  4. Study completionDec 2018

Resources

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
1,822 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02687035
Sponsor's protocol ID
2010-12 S3iCAP
Acronym
PII S3i CAP
Status last verified
Dec 2020
First submitted
1 Feb 2016
Last updated
8 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Abbas AE, Ternacle J, Pibarot P, Xu K, Alu M, Rogers E, Hahn RT, Leon M, Thourani VH. Impact of Flow on Prosthesis-Patient Mismatch Following Transcatheter and Surgical Aortic Valve Replacement. Circ Cardiovasc Imaging. 2021 Aug;14(8):e012364. doi: 10.1161/CIRCIMAGING.120.012364. Epub 2021 Aug 13.

    PubMed 34387097

Questions about this trial

What is this clinical trial studying?

A study testing SAPIEN S3 valve in people with Aortic Stenosis, run by Edwards Lifesciences at 56 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 9 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: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 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?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: 30 days). The study lists 6 primary outcomes in all. 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 NCT02687035, which also lists 1 linked publication.

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 8 Apr 2021.

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