Symptomatic Severe Aortic StenosisPII S3HR/NR7NCT03222141
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
A study testing TAVR Implantation of the THV Prosthesis in people with Symptomatic Severe Aortic Stenosis, run by Edwards Lifesciences at 40 sites in 2 countries.
Trial summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- TAVR Implantation of the THV Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Oct 2013to Aug 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
- STS > 8
Who cannot join
- Pre-existing mechanical or bioprosthetic valve in any position.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States39 sites
Emory University
Atlanta, Georgia, 30322
Austin Heart, PLLC
Austin, Texas, 78756
MedStar Union Memorial Hospital
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22904
Northwestern Hospital
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
Dallas, Texas, 75230
University of Colorado Hospital
Denver, Colorado, 80045
Duke University
Durham, North Carolina, 27712
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University Health-Methodist Hospital
Indianapolis, Indiana, 46202
The University of Iowa
Iowa City, Iowa, 52242
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Winthrop University Hospital
Mineola, New York, 11501
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84157
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Cornell University
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Providence St.Vincent Medical Center
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
Mercy General Hospital
Sacramento, California, 95819
University of Washington
Seattle, Washington, 98195
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Washington Hospital Center DC
Washington D.C., District of Columbia, 20010
York Hospital
York, Pennsylvania, 17403
Canada1 site
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.
Read the detailed description
This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- TAVR Implantation of the THV Prosthesis
- Keywords
- SAPIEN 3, Transfemoral, Transapical, Transaortic, TAVI, Aortic Stenosis, THV, Aortic Valve, Transcatheter Heart Valve, TAVR
- 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.
TAVR Implantation of the THV ProsthesisDevice
Also called SAPIEN 3™valve
Patients with TAVR implantation
| Study group | Role | What they receive |
|---|---|---|
| SAPIEN 3™ valve | Experimental | Not described Receives: Device: TAVR Implantation of the THV Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 Days
Secondary outcomes (2)
Number of Participants With Major Vascular Complications
The rate of major vascular complications at 30 days post implantation
Measured: 30 Days
Number of Participants With Aortic Insufficiency at 30 Days
The proportion of patients with aortic insufficiency ≥ moderate at 30 days.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startOct 2013
- Primary completionSep 2015
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Severe 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
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin B Leon, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222141
- Sponsor's protocol ID
- 2010-12 S3HR/NR7
- Acronym
- PII S3HR/NR7
- Status last verified
- Apr 2021
- First submitted
- 17 Jul 2017
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35041482Ong 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.
PubMed 33334422Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
PubMed 31883339Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
PubMed 31690104
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients
- ClinicalTrials.gov ID
- NCT03222141
- Acronym / sponsor ID
- PII S3HR/NR7 / 2010-12 S3HR/NR7
- Conditions
- Symptomatic Severe Aortic Stenosis
- Keywords
- SAPIEN 3, Transfemoral, Transapical, Transaortic, TAVI, Aortic Stenosis, THV, Aortic Valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Posted 14 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.
Detailed description
This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAPIEN 3™ valve | Experimental | Device: TAVR Implantation of the THV Prosthesis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (5 listed)
- Pre-existing mechanical or bioprosthetic valve in any position.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
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 |
|---|---|---|
| TAVR Implantation of the THV ProsthesisAlso: SAPIEN 3™valvePatients with TAVR implantation | Device | SAPIEN 3™ valve |
Primary outcome
The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate
Time frame: 30 Days
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).
2 secondary outcomes
Number of Participants With Major Vascular Complications
Time frame: 30 Days
Number of Participants With Aortic Insufficiency at 30 Days
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35041482Vincent 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.
- Derived from this study: PubMed 33334422Ong 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.
- Derived from this study: PubMed 31883339Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
- Derived from this study: PubMed 31690104Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martin B Leon, MD principal investigator
Columbia University
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR Implantation of the THV Prosthesis in people with Symptomatic Severe Aortic Stenosis, run by Edwards Lifesciences at 40 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 5 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 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 14 Aug 2018). 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?
The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate (time frame: 30 Days). 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 NCT03222141, which also lists 4 linked publications.
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 12 May 2021.