THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
NCT ID: NCT00530894
Last Updated: 2017-09-13
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1057 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-04-30
Study Completion Date
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
NCT03222141
Symptomatic Severe Aortic Stenosis
COMPLETED
NA
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
NCT03222128
Symptomatic Severe Aortic Stenosis
COMPLETED
NA
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
NCT03225001
Aortic Stenosis
Cardiomyopathy, Hypertrophic
COMPLETED
NA
PARTNER 3 Trial - Aortic Valve-in-Valve
NCT03003299
Aortic Stenosis
Aortic Stenosis, Severe
RECRUITING
NA
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
NCT01314313
Symptomatic Severe Aortic Stenosis
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Critical Aortic Stenosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Cohort A: Sapien Valve
Group Type
EXPERIMENTAL
Edwards SAPIEN Transcatheter Heart Valve
Intervention Type
DEVICE
2
Cohort A: other surgical valve
Group Type
ACTIVE_COMPARATOR
Surgical Valve Replacement
Intervention Type
DEVICE
3
Cohort B: Sapien Valve
Group Type
EXPERIMENTAL
Edwards SAPIEN Transcatheter Heart Valve
Intervention Type
DEVICE
4
Cohort B: Medical therapy
Group Type
ACTIVE_COMPARATOR
medical management and/or balloon aortic valvuloplasty
Intervention Type
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Edwards SAPIEN Transcatheter Heart Valve
Intervention Type
DEVICE
Surgical Valve Replacement
Intervention Type
DEVICE
medical management and/or balloon aortic valvuloplasty
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10
2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2
3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
4. The subject or the subject'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 IRB of the respective clinical site
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and
6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.
2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2
3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
4. The subject or the subject'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 IRB of the respective clinical site
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and
6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.
Exclusion Criteria
1. Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edwards Lifesciences
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin B Leon, MD
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian Hospital/Columbia University Medical Center
Craig Smith, MD
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian Hospital/Columbia University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scripps Memorial Hospital/Scripps Green Hospital
La Jolla, California, United States
Site Status
Cedars Sinai Medical Center
Los Angeles, California, United States
Site Status
Stanford University Medical Center
Stanford, California, United States
Site Status
Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
University of Miami
Miami, Florida, United States
Site Status
Emory University Hospital
Atlanta, Georgia, United States
Site Status
Northwestern University
Chicago, Illinois, United States
Site Status
NorthShore University HealthSystem
Evanston, Illinois, United States
Site Status
Ochsner Clinic
New Orleans, Louisiana, United States
Site Status
Boston Mass General
Boston, Massachusetts, United States
Site Status
Brigham and Women's
Boston, Massachusetts, United States
Site Status
Mayo Clinic-Saint Marys Hospital
Rochester, Minnesota, United States
Site Status
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Site Status
Barnes-Jewish/Washington University
St Louis, Missouri, United States
Site Status
New York Presbyterian Hospital - Cornell
New York, New York, United States
Site Status
Columbia University Medical Center
New York, New York, United States
Site Status
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Medical City Dallas
Dallas, Texas, United States
Site Status
Intermountain Medical Center
Murray, Utah, United States
Site Status
University of Virginia
Charlottesville, Virginia, United States
Site Status
University of Washington
Seattle, Washington, United States
Site Status
Vancouver St. Paul's
Vancouver, British Columbia, Canada
Site Status
Toronto General Hospital
Toronto, Ontario, Canada
Site Status
Laval Hospital
Québec, , Canada
Site Status
Heart Center Leipzig
Leipzig, , Germany
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Canada
Germany
References
Explore related publications, articles, or registry entries linked to this study.
Huded CP, Arnold SV, Chhatriwalla AK, Saxon JT, Kapadia S, Yu X, Webb JG, Thourani VH, Kodali SK, Smith CR, Mack MJ, Leon MB, Cohen DJ. Rehospitalization Events After Aortic Valve Replacement: Insights From the PARTNER Trial. Circ Cardiovasc Interv. 2022 Dec;15(12):e012195. doi: 10.1161/CIRCINTERVENTIONS.122.012195. Epub 2022 Dec 20.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Summers 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.
Reference Type
DERIVED
Kapadia SR, Huded CP, Kodali SK, Svensson LG, Tuzcu EM, Baron SJ, Cohen DJ, Miller DC, Thourani VH, Herrmann HC, Mack MJ, Szerlip M, Makkar RR, Webb JG, Smith CR, Rajeswaran J, Blackstone EH, Leon MB; PARTNER Trial Investigators. Stroke After Surgical Versus Transfemoral Transcatheter Aortic Valve Replacement in the PARTNER Trial. J Am Coll Cardiol. 2018 Nov 13;72(20):2415-2426. doi: 10.1016/j.jacc.2018.08.2172.
Reference Type
DERIVED
Elmariah S, Fearon WF, Inglessis I, Vlahakes GJ, Lindman BR, Alu MC, Crowley A, Kodali S, Leon MB, Svensson L, Pibarot P, Hahn RT, Thourani VH, Palacios IF, Miller DC, Douglas PS, Passeri JJ; PARTNER Trial Investigators and PARTNER Publications Office. Transapical Transcatheter Aortic Valve Replacement Is Associated With Increased Cardiac Mortality in Patients With Left Ventricular Dysfunction: Insights From the PARTNER I Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2414-2422. doi: 10.1016/j.jcin.2017.09.023.
Reference Type
DERIVED
Douglas PS, Leon MB, Mack MJ, Svensson LG, Webb JG, Hahn RT, Pibarot P, Weissman NJ, Miller DC, Kapadia S, Herrmann HC, Kodali SK, Makkar RR, Thourani VH, Lerakis S, Lowry AM, Rajeswaran J, Finn MT, Alu MC, Smith CR, Blackstone EH; PARTNER Trial Investigators. Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial. JAMA Cardiol. 2017 Nov 1;2(11):1197-1206. doi: 10.1001/jamacardio.2017.3306.
Reference Type
DERIVED
Lindman BR, Otto CM, Douglas PS, Hahn RT, Elmariah S, Weissman NJ, Stewart WJ, Ayele GM, Zhang F, Zajarias A, Maniar HS, Jilaihawi H, Blackstone E, Chinnakondepalli KM, Tuzcu EM, Leon MB, Pibarot P. Blood Pressure and Arterial Load After Transcatheter Aortic Valve Replacement for Aortic Stenosis. Circ Cardiovasc Imaging. 2017 Jul;10(7):e006308. doi: 10.1161/CIRCIMAGING.116.006308.
Reference Type
DERIVED
Beohar N, Doshi D, Thourani V, Jensen H, Kodali S, Zhang F, Zhang Y, Davidson C, McCarthy P, Mack M, Kapadia S, Leon M, Kirtane A. Association of Transcatheter Aortic Valve Replacement With 30-Day Renal Function and 1-Year Outcomes Among Patients Presenting With Compromised Baseline Renal Function: Experience From the PARTNER 1 Trial and Registry. JAMA Cardiol. 2017 Jul 1;2(7):742-749. doi: 10.1001/jamacardio.2017.1220.
Reference Type
DERIVED
Daubert MA, Weissman NJ, Hahn RT, Pibarot P, Parvataneni R, Mack MJ, Svensson LG, Gopal D, Kapadia S, Siegel RJ, Kodali SK, Szeto WY, Makkar R, Leon MB, Douglas PS. Long-Term Valve Performance of TAVR and SAVR: A Report From the PARTNER I Trial. JACC Cardiovasc Imaging. 2016 Dec 8:S1936-878X(16)30895-6. doi: 10.1016/j.jcmg.2016.11.004. Online ahead of print.
Reference Type
DERIVED
Kapadia S, Agarwal S, Miller DC, Webb JG, Mack M, Ellis S, Herrmann HC, Pichard AD, Tuzcu EM, Svensson LG, Smith CR, Rajeswaran J, Ehrlinger J, Kodali S, Makkar R, Thourani VH, Blackstone EH, Leon MB. Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves). Circ Cardiovasc Interv. 2016 Sep;9(9):e002981. doi: 10.1161/CIRCINTERVENTIONS.115.002981.
Reference Type
DERIVED
Anjan VY, Herrmann HC, Pibarot P, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani VH, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB. Evaluation of Flow After Transcatheter Aortic Valve Replacement in Patients With Low-Flow Aortic Stenosis: A Secondary Analysis of the PARTNER Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):584-92. doi: 10.1001/jamacardio.2016.0759.
Reference Type
DERIVED
Suri RM, Minha S, Alli O, Waksman R, Rihal CS, Satler LP, Greason KL, Torguson R, Pichard AD, Mack M, Svensson LG, Rajeswaran J, Lowry AM, Ehrlinger J, Mick SL, Tuzcu EM, Thourani VH, Makkar R, Holmes D, Leon MB, Blackstone EH. Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety. J Thorac Cardiovasc Surg. 2016 Sep;152(3):773-780.e14. doi: 10.1016/j.jtcvs.2016.04.028. Epub 2016 Apr 13.
Reference Type
DERIVED
Kodali S, Williams MR, Doshi D, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, Douglas PS, Mack M, Xu K, Svensson L, Thourani VH, Tuzcu EM, Weissman NJ, Leon M, Kirtane AJ. Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study. Ann Intern Med. 2016 Mar 15;164(6):377-84. doi: 10.7326/M15-0121. Epub 2016 Feb 23.
Reference Type
DERIVED
Beohar N, Kirtane AJ, Blackstone E, Waksman R, Holmes D Jr, Minha S, Alli O, Suri RM, Svensson LG, Leon M, Kodali S. Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry. JACC Cardiovasc Interv. 2016 Feb 22;9(4):355-363. doi: 10.1016/j.jcin.2015.10.050. Epub 2016 Jan 20.
Reference Type
DERIVED
Biviano AB, Nazif T, Dizon J, Garan H, Fleitman J, Hassan D, Kapadia S, Babaliaros V, Xu K, Parvataneni R, Rodes-Cabau J, Szeto WY, Fearon WF, Dvir D, Dewey T, Williams M, Mack MJ, Webb JG, Miller DC, Smith CR, Leon MB, Kodali S. Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Placement of Aortic Transcatheter Valve (PARTNER) Trial. Circ Cardiovasc Interv. 2016 Jan;9(1):e002766. doi: 10.1161/CIRCINTERVENTIONS.115.002766.
Reference Type
DERIVED
Lindman BR, Zajarias A, Maniar HS, Miller DC, Suri RM, Arnold SV, Webb J, Svensson LG, Kodali S, Xu K, Ayele GM, Lin F, Wong SC, Babaliaros V, Thourani VH, Douglas PS, Lim S, Leon MB, Mack MJ. Risk stratification in patients with pulmonary hypertension undergoing transcatheter aortic valve replacement. Heart. 2015 Oct;101(20):1656-64. doi: 10.1136/heartjnl-2015-308001. Epub 2015 Aug 11.
Reference Type
DERIVED
Dizon JM, Nazif TM, Hess PL, Biviano A, Garan H, Douglas PS, Kapadia S, Babaliaros V, Herrmann HC, Szeto WY, Jilaihawi H, Fearon WF, Tuzcu EM, Pichard AD, Makkar R, Williams M, Hahn RT, Xu K, Smith CR, Leon MB, Kodali SK; PARTNER Publications Office. Chronic pacing and adverse outcomes after transcatheter aortic valve implantation. Heart. 2015 Oct;101(20):1665-71. doi: 10.1136/heartjnl-2015-307666. Epub 2015 Aug 10.
Reference Type
DERIVED
Thourani VH, Jensen HA, Babaliaros V, Kodali SK, Rajeswaran J, Ehrlinger J, Blackstone EH, Suri RM, Don CW, Aldea G, Williams MR, Makkar R, Svensson LG, McCabe JM, Dean LS, Kapadia S, Cohen DJ, Pichard AD, Szeto WY, Herrmann HC, Devireddy C, Leshnower BG, Ailawadi G, Maniar HS, Hahn RT, Leon MB, Mack M. Outcomes in Nonagenarians Undergoing Transcatheter Aortic Valve Replacement in the PARTNER-I Trial. Ann Thorac Surg. 2015 Sep;100(3):785-92; discussion 793. doi: 10.1016/j.athoracsur.2015.05.021. Epub 2015 Aug 1.
Reference Type
DERIVED
Szeto WY, Svensson LG, Rajeswaran J, Ehrlinger J, Suri RM, Smith CR, Mack M, Miller DC, McCarthy PM, Bavaria JE, Cohn LH, Corso PJ, Guyton RA, Thourani VH, Lytle BW, Williams MR, Webb JG, Kapadia S, Tuzcu EM, Cohen DJ, Schaff HV, Leon MB, Blackstone EH; Placement of Aortic Transcatheter Valves Trial Investigators. Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial. J Thorac Cardiovasc Surg. 2015 Sep;150(3):557-68.e11. doi: 10.1016/j.jtcvs.2015.05.073. Epub 2015 Jun 30.
Reference Type
DERIVED
Gada H, Kirtane AJ, Wang K, Lei Y, Magnuson E, Reynolds MR, Williams MR, Kodali S, Vahl TP, Arnold SV, Leon MB, Thourani V, Szeto WY, Cohen DJ; PARTNER Investigators. Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):338-46. doi: 10.1161/CIRCOUTCOMES.114.001335. Epub 2015 Jun 9.
Reference Type
DERIVED
Green P, Arnold SV, Cohen DJ, Kirtane AJ, Kodali SK, Brown DL, Rihal CS, Xu K, Lei Y, Hawkey MC, Kim RJ, Alu MC, Leon MB, Mack MJ. Relation of frailty to outcomes after transcatheter aortic valve replacement (from the PARTNER trial). Am J Cardiol. 2015 Jul 15;116(2):264-9. doi: 10.1016/j.amjcard.2015.03.061. Epub 2015 Apr 18.
Reference Type
DERIVED
Blackstone EH, Suri RM, Rajeswaran J, Babaliaros V, Douglas PS, Fearon WF, Miller DC, Hahn RT, Kapadia S, Kirtane AJ, Kodali SK, Mack M, Szeto WY, Thourani VH, Tuzcu EM, Williams MR, Akin JJ, Leon MB, Svensson LG. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy. Circulation. 2015 Jun 2;131(22):1989-2000. doi: 10.1161/CIRCULATIONAHA.114.012525. Epub 2015 Apr 1.
Reference Type
DERIVED
Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15.
Reference Type
DERIVED
Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, Webb JG, Mack MJ, Douglas PS, Thourani VH, Babaliaros VC, Herrmann HC, Szeto WY, Pichard AD, Williams MR, Fontana GP, Miller DC, Anderson WN, Akin JJ, Davidson MJ, Smith CR; PARTNER trial investigators. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2485-91. doi: 10.1016/S0140-6736(15)60290-2. Epub 2015 Mar 15.
Reference Type
DERIVED
Kapadia S, Stewart WJ, Anderson WN, Babaliaros V, Feldman T, Cohen DJ, Douglas PS, Makkar RR, Svensson LG, Webb JG, Wong SC, Brown DL, Miller DC, Moses JW, Smith CR, Leon MB, Tuzcu EM. Outcomes of inoperable symptomatic aortic stenosis patients not undergoing aortic valve replacement: insight into the impact of balloon aortic valvuloplasty from the PARTNER trial (Placement of AoRtic TraNscathetER Valve trial). JACC Cardiovasc Interv. 2015 Feb;8(2):324-333. doi: 10.1016/j.jcin.2014.08.015.
Reference Type
DERIVED
Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
Reference Type
DERIVED
Passeri JJ, Elmariah S, Xu K, Inglessis I, Baker JN, Alu M, Kodali S, Leon MB, Svensson LG, Pibarot P, Fearon WF, Kirtane AJ, Vlahakes GJ, Palacios IF, Douglas PS; PARTNER Investigators. Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF. Heart. 2015 Mar;101(6):463-71. doi: 10.1136/heartjnl-2014-306737. Epub 2015 Jan 13.
Reference Type
DERIVED
Genereux P, Cohen DJ, Mack M, Rodes-Cabau J, Yadav M, Xu K, Parvataneni R, Hahn R, Kodali SK, Webb JG, Leon MB. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2014 Dec 23;64(24):2605-2615. doi: 10.1016/j.jacc.2014.08.052.
Reference Type
DERIVED
Fearon WF, Kodali S, Doshi D, Fischbein MP, Yeung AC, Tuzcu EM, Rihal CS, Babaliaros V, Zajarias A, Herrmann HC, Brown DL, Mack M, Teirstein PS, Whisenant BK, Makkar R, Kapadia S, Leon MB; PARTNER Trial Investigators. Outcomes after transfemoral transcatheter aortic valve replacement: a comparison of the randomized PARTNER (Placement of AoRTic TraNscathetER Valves) trial with the NRCA (Nonrandomized Continued Access) registry. JACC Cardiovasc Interv. 2014 Nov;7(11):1245-51. doi: 10.1016/j.jcin.2014.05.033. Epub 2014 Nov 17.
Reference Type
DERIVED
Douglas PS, Hahn RT, Pibarot P, Weissman NJ, Stewart WJ, Xu K, Wang Z, Lerakis S, Siegel R, Thompson C, Gopal D, Keane MG, Svensson LG, Tuzcu EM, Smith CR, Leon MB. Hemodynamic outcomes of transcatheter aortic valve replacement and medical management in severe, inoperable aortic stenosis: a longitudinal echocardiographic study of cohort B of the PARTNER trial. J Am Soc Echocardiogr. 2015 Feb;28(2):210-7.e1-9. doi: 10.1016/j.echo.2014.10.009. Epub 2014 Nov 20.
Reference Type
DERIVED
Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, Petersen JL 2nd, Douglas PS, Svensson LG, Gada H, Thourani VH, Kodali SK, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial. Circ Cardiovasc Interv. 2014 Dec;7(6):829-36. doi: 10.1161/CIRCINTERVENTIONS.114.001395. Epub 2014 Oct 21.
Reference Type
DERIVED
Rodes-Cabau J, Pibarot P, Suri RM, Kodali S, Thourani VH, Szeto WY, Svensson LG, Dumont E, Xu K, Hahn RT, Leon MB. Impact of aortic annulus size on valve hemodynamics and clinical outcomes after transcatheter and surgical aortic valve replacement: insights from the PARTNER Trial. Circ Cardiovasc Interv. 2014 Oct;7(5):701-11. doi: 10.1161/CIRCINTERVENTIONS.114.001681. Epub 2014 Sep 30.
Reference Type
DERIVED
Pibarot P, Weissman NJ, Stewart WJ, Hahn RT, Lindman BR, McAndrew T, Kodali SK, Mack MJ, Thourani VH, Miller DC, Svensson LG, Herrmann HC, Smith CR, Rodes-Cabau J, Webb J, Lim S, Xu K, Hueter I, Douglas PS, Leon MB. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis. J Am Coll Cardiol. 2014 Sep 30;64(13):1323-34. doi: 10.1016/j.jacc.2014.06.1195.
Reference Type
DERIVED
Kapadia SR, Tuzcu EM, Makkar RR, Svensson LG, Agarwal S, Kodali S, Fontana GP, Webb JG, Mack M, Thourani VH, Babaliaros VC, Herrmann HC, Szeto W, Pichard AD, Williams MR, Anderson WN, Akin JJ, Miller DC, Smith CR, Leon MB. Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy. Circulation. 2014 Oct 21;130(17):1483-92. doi: 10.1161/CIRCULATIONAHA.114.009834. Epub 2014 Sep 9.
Reference Type
DERIVED
Svensson LG, Blackstone EH, Rajeswaran J, Brozzi N, Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Tuzcu EM, Webb JG, Kapadia S, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Thourani VH, Pichard AD, Bavaria JE, Herrmann HC, Williams MR, Babaliaros V, Genereux P, Akin JJ; PARTNER Trial Investigators. Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial. J Am Coll Cardiol. 2014 Jul 15;64(2):158-68. doi: 10.1016/j.jacc.2013.08.1666.
Reference Type
DERIVED
Arnold SV, Reynolds MR, Lei Y, Magnuson EA, Kirtane AJ, Kodali SK, Zajarias A, Thourani VH, Green P, Rodes-Cabau J, Beohar N, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Circulation. 2014 Jun 24;129(25):2682-90. doi: 10.1161/CIRCULATIONAHA.113.007477. Epub 2014 May 23.
Reference Type
DERIVED
Beohar N, Whisenant B, Kirtane AJ, Leon MB, Tuzcu EM, Makkar R, Svensson LG, Miller DC, Smith CR, Pichard AD, Herrmann HC, Thourani VH, Szeto WY, Lim S, Fischbein M, Fearon WF, O'Neill W, Xu K, Dewey T, Mack M. The relative performance characteristics of the logistic European System for Cardiac Operative Risk Evaluation score and the Society of Thoracic Surgeons score in the Placement of Aortic Transcatheter Valves trial. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2830-7.e1. doi: 10.1016/j.jtcvs.2014.04.006. Epub 2014 Apr 13.
Reference Type
DERIVED
Williams M, Kodali SK, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, Douglas PS, Mack M, McAndrew TC, Svensson L, Thourani VH, Tuzcu EM, Weissman NJ, Kirtane AJ, Leon MB. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Apr 22;63(15):1522-8. doi: 10.1016/j.jacc.2014.01.036. Epub 2014 Feb 19.
Reference Type
DERIVED
Genereux P, Cohen DJ, Williams MR, Mack M, Kodali SK, Svensson LG, Kirtane AJ, Xu K, McAndrew TC, Makkar R, Smith CR, Leon MB. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Mar 25;63(11):1100-9. doi: 10.1016/j.jacc.2013.10.058. Epub 2013 Nov 27.
Reference Type
DERIVED
Lindman BR, Pibarot P, Arnold SV, Suri RM, McAndrew TC, Maniar HS, Zajarias A, Kodali S, Kirtane AJ, Thourani VH, Tuzcu EM, Svensson LG, Waksman R, Smith CR, Leon MB. Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: an analysis of the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Mar 25;63(11):1090-9. doi: 10.1016/j.jacc.2013.10.057. Epub 2013 Nov 27.
Reference Type
DERIVED
Elmariah S, Palacios IF, McAndrew T, Hueter I, Inglessis I, Baker JN, Kodali S, Leon MB, Svensson L, Pibarot P, Douglas PS, Fearon WF, Kirtane AJ, Maniar HS, Passeri JJ; PARTNER Investigators. Outcomes of transcatheter and surgical aortic valve replacement in high-risk patients with aortic stenosis and left ventricular dysfunction: results from the Placement of Aortic Transcatheter Valves (PARTNER) trial (cohort A). Circ Cardiovasc Interv. 2013 Dec;6(6):604-14. doi: 10.1161/CIRCINTERVENTIONS.113.000650. Epub 2013 Nov 12.
Reference Type
DERIVED
Makkar RR, Jilaihawi H, Mack M, Chakravarty T, Cohen DJ, Cheng W, Fontana GP, Bavaria JE, Thourani VH, Herrmann HC, Pichard A, Kapadia S, Babaliaros V, Whisenant BK, Kodali SK, Williams M, Trento A, Smith CR, Teirstein PS, Cohen MG, Xu K, Tuzcu EM, Webb JG, Leon MB. Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. J Am Coll Cardiol. 2014 Mar 11;63(9):901-11. doi: 10.1016/j.jacc.2013.08.1641. Epub 2013 Oct 23.
Reference Type
DERIVED
Barbanti M, Webb JG, Hahn RT, Feldman T, Boone RH, Smith CR, Kodali S, Zajarias A, Thompson CR, Green P, Babaliaros V, Makkar RR, Szeto WY, Douglas PS, McAndrew T, Hueter I, Miller DC, Leon MB; Placement of Aortic Transcatheter Valve Trial Investigators. Impact of preoperative moderate/severe mitral regurgitation on 2-year outcome after transcatheter and surgical aortic valve replacement: insight from the Placement of Aortic Transcatheter Valve (PARTNER) Trial Cohort A. Circulation. 2013 Dec 24;128(25):2776-84. doi: 10.1161/CIRCULATIONAHA.113.003885. Epub 2013 Oct 23.
Reference Type
DERIVED
Dvir D, Waksman R, Barbash IM, Kodali SK, Svensson LG, Tuzcu EM, Xu K, Minha S, Alu MC, Szeto WY, Thourani VH, Makkar R, Kapadia S, Satler LF, Webb JG, Leon MB, Pichard AD. Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic TraNscathetER Valve). J Am Coll Cardiol. 2014 Jan 28;63(3):269-79. doi: 10.1016/j.jacc.2013.09.024. Epub 2013 Oct 16.
Reference Type
DERIVED
Green P, Cohen DJ, Genereux P, McAndrew T, Arnold SV, Alu M, Beohar N, Rihal CS, Mack MJ, Kapadia S, Dvir D, Maurer MS, Williams MR, Kodali S, Leon MB, Kirtane AJ. Relation between six-minute walk test performance and outcomes after transcatheter aortic valve implantation (from the PARTNER trial). Am J Cardiol. 2013 Sep 1;112(5):700-6. doi: 10.1016/j.amjcard.2013.04.046. Epub 2013 May 29.
Reference Type
DERIVED
Makkar RR, Jilaihawi H, Chakravarty T, Fontana GP, Kapadia S, Babaliaros V, Cheng W, Thourani VH, Bavaria J, Svensson L, Kodali S, Shiota T, Siegel R, Tuzcu EM, Xu K, Hahn RT, Herrmann HC, Reisman M, Whisenant B, Lim S, Beohar N, Mack M, Teirstein P, Rihal C, Douglas PS, Blackstone E, Pichard A, Webb JG, Leon MB. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). J Am Coll Cardiol. 2013 Jul 30;62(5):418-30. doi: 10.1016/j.jacc.2013.04.037. Epub 2013 May 15.
Reference Type
DERIVED
Herrmann HC, Pibarot P, Hueter I, Gertz ZM, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani V, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB. Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis. Circulation. 2013 Jun 11;127(23):2316-26. doi: 10.1161/CIRCULATIONAHA.112.001290. Epub 2013 May 9.
Reference Type
DERIVED
Hahn RT, Pibarot P, Stewart WJ, Weissman NJ, Gopalakrishnan D, Keane MG, Anwaruddin S, Wang Z, Bilsker M, Lindman BR, Herrmann HC, Kodali SK, Makkar R, Thourani VH, Svensson LG, Akin JJ, Anderson WN, Leon MB, Douglas PS. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (placement of aortic transcatheter valves). J Am Coll Cardiol. 2013 Jun 25;61(25):2514-21. doi: 10.1016/j.jacc.2013.02.087. Epub 2013 Apr 23.
Reference Type
DERIVED
Reynolds MR, Magnuson EA, Lei Y, Wang K, Vilain K, Li H, Walczak J, Pinto DS, Thourani VH, Svensson LG, Mack MJ, Miller DC, Satler LE, Bavaria J, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol. 2012 Dec 25;60(25):2683-92. doi: 10.1016/j.jacc.2012.09.018. Epub 2012 Nov 1.
Reference Type
DERIVED
Green P, Woglom AE, Genereux P, Daneault B, Paradis JM, Schnell S, Hawkey M, Maurer MS, Kirtane AJ, Kodali S, Moses JW, Leon MB, Smith CR, Williams M. The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience. JACC Cardiovasc Interv. 2012 Sep;5(9):974-81. doi: 10.1016/j.jcin.2012.06.011.
Reference Type
DERIVED
Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, Rihal CS, Brown DL, Smith CR, Leon MB, Cohen DJ; PARTNER Trial Investigators. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012 Aug 7;60(6):548-58. doi: 10.1016/j.jacc.2012.03.075. Epub 2012 Jul 18.
Reference Type
DERIVED
Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
Reference Type
DERIVED
Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.
Reference Type
DERIVED
Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.
Reference Type
DERIVED
Reynolds MR, Magnuson EA, Wang K, Lei Y, Vilain K, Walczak J, Kodali SK, Lasala JM, O'Neill WW, Davidson CJ, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation. 2012 Mar 6;125(9):1102-9. doi: 10.1161/CIRCULATIONAHA.111.054072. Epub 2012 Feb 3.
Reference Type
DERIVED
Reynolds MR, Magnuson EA, Lei Y, Leon MB, Smith CR, Svensson LG, Webb JG, Babaliaros VC, Bowers BS, Fearon WF, Herrmann HC, Kapadia S, Kodali SK, Makkar RR, Pichard AD, Cohen DJ; Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.
Reference Type
DERIVED
Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
Reference Type
DERIVED
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-06-US
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
NCT02675114
ACTIVE_NOT_RECRUITING
NA
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
NCT02184442
COMPLETED
NA
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
NCT01808287
COMPLETED
NA
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
NCT00820599
COMPLETED
NA
PARTNER II Trial: S3iCAP
NCT02687035
COMPLETED
NA
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
NCT04889872
RECRUITING
NA
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
NCT03471065
COMPLETED
NA
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
NCT04722250
ACTIVE_NOT_RECRUITING
NA
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
NCT04843072
RECRUITING
NA
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
NCT05172960
ACTIVE_NOT_RECRUITING
NA
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
NCT01808274
COMPLETED
NA
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
NCT03517436
ACTIVE_NOT_RECRUITING
NA
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
NCT02698956
COMPLETED
Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.
NCT03011346
COMPLETED
NA
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
NCT01238835
COMPLETED
NA
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
NCT05172973
RECRUITING
NA
Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
NCT05454150
ACTIVE_NOT_RECRUITING
NA
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
NCT07116551
RECRUITING
NA
Mitral Implantation of TRAnscatheter vaLves
NCT02370511
COMPLETED
NA
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
NCT06167213
NOT_YET_RECRUITING
NA
transShield Embolic Protection System Feasibility Study
NCT04585308
COMPLETED
NA
Transcatheter Aortic Valve Replacement System Pivotal Trial
NCT02163850
UNKNOWN
NA
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
NCT02202434
TERMINATED
NA
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
NCT04149535
COMPLETED
NA