Symptomatic Severe Aortic StenosisPII ANCT01314313
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
A study testing TAVR Implantation with SAPIEN XT and SAVR Implantation in people with Symptomatic Severe Aortic Stenosis, run by Edwards Lifesciences at 57 sites in 2 countries.
Trial summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- TAVR Implantation with SAPIEN XT and SAVR Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,032 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Mar 2011to 17 Jan 2024
- Phase
- Interventional
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 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.
- Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.
Who cannot join
- 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 regurgitation with predominant aortic regurgitation >3+).
- Preexisting mechanical or bioprosthetic valve in any position (except NR3).
- 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 (S3 Cohort only) is not excluded.
- Heart team assessment of inoperability (including examining cardiac surgeon).
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States55 sites
Emory University
Atlanta, Georgia, 30322
Austin Heart, PLLC
Austin, Texas, 78756
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cooper University
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22904
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The Lindner Center for Research & Education at 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
Dallas, Texas, 75230
University of Colorado Hospital
Denver, Colorado, 80045
Henry Ford Hospital
Detroit, Michigan, 48202
Northshore
Evanston, Illinois, 60201
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, 27834
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
St. Luke's Hospital - Mid America Heart Institute
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
Arkansas Heart Hospital/Clinic
Little Rock, Arkansas, 72211
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Jewish Hospital Medical Center
Louisville, Kentucky, 40202
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Baptist Memorial Hospital
Memphis, Tennessee, 38120
University of Miami Hospital Miller School of Medicine
Miami, Florida, 33136
Winthrop University Hospital
Mineola, New York, 11501
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
IHC Health Services Inc. dba Intermountain Medical Center
Murray, Utah, 84157
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
New York Presbyterian Hospital - Cornell
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 Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Providence Heart & Vascular Institute at 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, 95816
UC Davis Medical Center
Sacramento, California, 95817
University of Texas Health Science Center at San Antonio (UTHSCSA)
San Antonio, Texas, 78229-3900
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
Washington D.C., District of Columbia, 20010
York Hospital
York, Pennsylvania, 17403
Canada2 sites
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V465
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Read the detailed description
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.
To assure that patients with an STS score ≥ 4% have been selected.
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Keywords
- SAPIEN XT, Transfemoral, Transapical, Transaortic, NovaFlex, 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 with SAPIEN XTDevice
Operable Group with SAPIEN XT
SAVR ImplantationDevice
Control Group
| Study group | Role | What they receive |
|---|---|---|
| PIIA - SAPIEN XT | Experimental | PIIA is operable group Receives: Device: TAVR Implantation with SAPIEN XT |
| Control: SAVR | Active comparator | SAVR (surgical aortic valve replacement) is the control arm Receives: Device: SAVR Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Death or Disabling Stroke to Two Years
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Measured: 2 Years
Secondary outcomes (5)
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
The number of days the patients are alive and out of the hospital.
Measured: 2 years
Total Aortic Regurgitation (AR) at 2 Years
Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
Measured: 2 years
6MWT Change From Baseline
Six Minute Walk Test change from baseline to 2 years
Measured: Baseline and 2 years
NYHA Classification at 2 Years
New York Heart Association (NYHA), 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 as no limitations and the highest unable to carry on any physical activity without discomfort.
Measured: 2 years
Effective Orifice Area (EOA)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2016
- Study completion17 Jan 2024
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 (25)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,032 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 UniversityCraig Smith, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314313
- Sponsor's protocol ID
- 2010-12 PIIA
- Acronym
- PII A
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2011
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Thourani VH, von Stein P, Mack MJ, Nazif TM, Babaliaros V, Alkhouli M, Fischbein MP, Desai ND, Satler L, Zidar FJ, Kodali SK, Kron IL, Zajarias A, Brinkman W, Kapadia S, Dewey TM, Gossl M, Bodenhamer RM, Ma Y, Cohen DJ, Sharma R, Pibarot P, Hahn RT, Leon MB, Makkar RR; PARTNER 2 Investigators. 10-Year Randomized Outcomes of Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Aortic Stenosis. J Am Coll Cardiol. 2026 Jun 16;87(23):3309-3321. doi: 10.1016/j.jacc.2026.03.169.
PubMed 42300821Madhavan MV, Kodali SK, Thourani VH, Makkar R, Mack MJ, Kapadia S, Webb JG, Cohen DJ, Herrmann HC, Williams M, Greason K, Pibarot P, Hahn RT, Jaber W, Xu K, Alu M, Smith CR, Leon MB. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2023 Jul 11;82(2):109-123. doi: 10.1016/j.jacc.2023.04.049.
PubMed 37407110Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
PubMed 35595203Vincent 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 35041482Abbas 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 34387097Cremer PC, Wang TKM, Rodriguez LL, Lindman BR, Zhang Y, Zajarias A, Hahn RT, Lerakis S, Malaisrie SC, Douglas PS, Pibarot P, Svensson LG, Kapadia S, Leon MB, Jaber WA; PARTNER II Investigators. Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial. Circ Cardiovasc Interv. 2021 Aug;14(8):e010437. doi: 10.1161/CIRCINTERVENTIONS.120.010437. Epub 2021 Jul 16.
PubMed 34266311Brener MI, George I, Kosmidou I, Nazif T, Zhang Z, Dizon JM, Garan H, Malaisrie SC, Makkar R, Mack M, Szeto WY, Fearon WF, Thourani VH, Leon MB, Kodali S, Biviano AB. Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials. J Am Heart Assoc. 2021 Apr 6;10(7):e019584. doi: 10.1161/JAHA.120.019584. Epub 2021 Mar 23.
PubMed 33754803Pibarot P, Ternacle J, Jaber WA, Salaun E, Dahou A, Asch FM, Weissman NJ, Rodriguez L, Xu K, Annabi MS, Guzzetti E, Beaudoin J, Bernier M, Leipsic J, Blanke P, Clavel MA, Rogers E, Alu MC, Douglas PS, Makkar R, Miller DC, Kapadia SR, Mack MJ, Webb JG, Kodali SK, Smith CR, Herrmann HC, Thourani VH, Leon MB, Hahn RT; PARTNER 2 Investigators. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020 Oct 20;76(16):1830-1843. doi: 10.1016/j.jacc.2020.08.049.
PubMed 33059828Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, Yoon SH, Trento A, Svensson LG, Herrmann HC, Szeto WY, Miller DC, Satler L, Cohen DJ, Dewey TM, Babaliaros V, Williams MR, Kereiakes DJ, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Brown DL, Fearon WF, Russo MJ, Pibarot P, Hahn RT, Jaber WA, Rogers E, Xu K, Wheeler J, Alu MC, Smith CR, Leon MB; PARTNER 2 Investigators. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020 Jan 29;382(9):799-809. doi: 10.1056/NEJMoa1910555. Print 2020 Feb 27.
PubMed 31995682Chen 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 31690104Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
PubMed 31525069Nazif TM, Chen S, George I, Dizon JM, Hahn RT, Crowley A, Alu MC, Babaliaros V, Thourani VH, Herrmann HC, Smalling RW, Brown DL, Mack MJ, Kapadia S, Makkar R, Webb JG, Leon MB, Kodali SK. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019 Jul 14;40(27):2218-2227. doi: 10.1093/eurheartj/ehz227.
PubMed 31505615Chakravarty T, Patel A, Kapadia S, Raschpichler M, Smalling RW, Szeto WY, Abramowitz Y, Cheng W, Douglas PS, Hahn RT, Herrmann HC, Kereiakes D, Svensson L, Yoon SH, Babaliaros VC, Kodali S, Thourani VH, Alu MC, Liu Y, McAndrew T, Mack M, Leon MB, Makkar RR. Anticoagulation After Surgical or Transcatheter Bioprosthetic Aortic Valve Replacement. J Am Coll Cardiol. 2019 Sep 3;74(9):1190-1200. doi: 10.1016/j.jacc.2019.06.058.
PubMed 31466616Baron SJ, Wang K, House JA, Magnuson EA, Reynolds MR, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Mack MJ, Brown DL, Russo MJ, Smith CR, Webb J, Miller C, Leon MB, Cohen DJ. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk. Circulation. 2019 Feb 12;139(7):877-888. doi: 10.1161/CIRCULATIONAHA.118.035236.
PubMed 30586747