Aortic StenosisPII NR3/ViVNCT03225001

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

A study testing Edwards SAPIEN XT transcatheter valve, Model 9300TFX in people with Aortic Stenosis and Cardiomyopathy, Hypertrophic, run by Edwards Lifesciences at 47 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

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve. Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Stenosis, Cardiomyopathy, Hypertrophic
What is being tested?: Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 197 participants
Where: 47 sitesin 2 countries
Study dates: 11 Jun 2012to 28 Oct 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 Any age
All sexes
No healthy volunteers
Child, 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 was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.

Who cannot join

Bioprosthetic valve labeled external diameter < 21mm.
Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
Infectious endocarditis within 6 months.
Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.

Trial locations and contacts

47 sites in 2 countries.

Country

City, postcode or hospital

47 sites in 2 countries

United States46 sites

University of Michigan
Ann Arbor, Michigan, 48130
Emory University Hospital
Atlanta, Georgia, 30341
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22904
Northwestern Hospital
Chicago, Illinois, 60611
The Christ Hospital
Cincinnati, Ohio, 45219
Morton Plant Hospital
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Heart Hospital Baylor Plano
Dallas, Texas, 75093
Medical City Dallas Hospital
Dallas, Texas, 75230
University of Colorado Hospital
Denver, Colorado, 80045
Henry Ford Hospital
Detroit, Michigan, 48202
NorthShore University HealthSystem Research Institute
Evanston, Illinois, 60201
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, 27834
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
Houston, Texas, 77030
The University of Iowa
Iowa City, Iowa, 52242
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111
Scripps Green Hospital
La Jolla, California, 92037
Scripps Memorial Hospital
La Jolla, California, 92037
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
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
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 Presbyterian Hospital
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
Providence St.Vincent Medical Center
Portland, Oregon, 97225
Mayo Clinic-Saint Marys Hospital
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
Mercy General Hospital
Sacramento, California, 95819
Intermountain Medical Center
Salt Lake City, Utah, 84157
University of Washington
Seattle, Washington, 98101
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 (WHC)
Washington D.C., District of Columbia, 20010

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: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Read the detailed description

A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.

Conditions: Aortic Stenosis, Cardiomyopathy, Hypertrophic
Being tested: Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Keywords: SAPIEN XT, Partner II, cardiovascular disease, heart disease, aortic disease, SAVR, TAVR, failing surgical valve, failing valve, failing bioprosthetic valve
Medical subject headings: Aortic Valve Stenosis, Cardiomyopathy, Hypertrophic, Cardiovascular Diseases, Heart Diseases, Aortic Diseases

What participants receive

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

Edwards SAPIEN XT transcatheter valve, Model 9300TFXDevice
Also called TAVI
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.

Study groups in NCT03225001
Study group	Role	What they receive
Failing surgical valve	Experimental	Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve. Receives: Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX

What is being measured

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

Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
Measured: 30-day

Secondary outcomes (1)

Number of Participants With Mortality From Any Cause
Cardiovascular cause is also included
Measured: 30 Days

Timeline

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

11 Jun 201228 Oct 2020

First posted21 Jul 2017
Study start11 Jun 2012
Primary completion16 Dec 2016
Study completion28 Oct 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 (2)Papers the sponsor has linked to this study.
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: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03225001
Sponsor's protocol ID: 2010-12 NR3/ViV
Acronym: PII NR3/ViV
Status last verified: Feb 2021
First submitted: 17 Jul 2017
Last updated: 9 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
PubMed 35656983
Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.
PubMed 31146808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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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
Recruiting
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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
ClinicalTrials.gov ID: NCT03225001
Acronym / sponsor ID: PII NR3/ViV / 2010-12 NR3/ViV
Conditions: Aortic Stenosis, Cardiomyopathy, Hypertrophic
Keywords: SAPIEN XT, Partner II, cardiovascular disease, heart disease, aortic disease, SAVR, TAVR, failing surgical valve
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 11 Jun 2012 (actual)
Primary completion: 16 Dec 2016 (actual)
Study completion: 28 Oct 2020 (actual)
First posted: 21 Jul 2017 (actual)
Results: Posted 9 Jan 2018

Clinical summary

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

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Detailed description

Study design

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

Arm	Type	Receives
Failing surgical valve	Experimental	Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFXPatients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, 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 was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.

Key exclusion criteria (4 listed)

Bioprosthetic valve labeled external diameter < 21mm.
Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
Infectious endocarditis within 6 months.
Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.

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 XT transcatheter valve, Model 9300TFXAlso: TAVIEdwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.	Device	Failing surgical valve

Primary outcome

Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
Time frame: 30-day
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak

1 secondary outcome

Number of Participants With Mortality From Any Cause
Time frame: 30 Days

Results and safety

Results posted to the registry on 9 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Edwards SAPIEN XT THV in Patients With Failing SAVR	197	188

Primary outcome: Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)

Time frame: 30-day. Count of participants. Unit: Participants

Measure	Edwards SAPIEN XT THV in Patients With Failing SAVR n = 166
Value	28

Population analysed: Twenty-nine patients had missing echocardiography data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30-day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Edwards SAPIEN XT THV in Patients With Failing SAVR	109 of 195 (55.9%)	142 of 195 (72.8%)	8 of 195

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35656983Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
Derived from this study: PubMed 31146808Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
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
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. This study is not recruiting at the moment.

John Webb, MD principal investigator

St. Paul's Hospital, Vancouver, British columbia, Canada

Michael Mack, MD principal investigator

Baylor Heart Hospital, Plano, TX

47 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 XT transcatheter valve, Model 9300TFX in people with Aortic Stenosis and Cardiomyopathy, Hypertrophic, run by Edwards Lifesciences at 47 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 4 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 9 Jan 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?

Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) (time frame: 30-day). 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 NCT03225001, which also lists 2 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 9 Mar 2021.