Critical Aortic StenosisPARTNERNCT00530894
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
A study testing Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement and medical management and/or balloon aortic valvuloplasty in people with Critical Aortic Stenosis, run by Edwards Lifesciences at 26 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Aortic Stenosis
- What is being tested?
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement and medical management and/or balloon aortic valvuloplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,057 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Apr 2007to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must 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
- 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
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
- 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
- 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
- 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%.
Who cannot join
- Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- 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).
- Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States22 sites
Emory University Hospital
Atlanta, Georgia, 30322
Boston Mass General
Boston, Massachusetts, 02114
Brigham and Women's
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Medical City Dallas
Dallas, Texas, 75230
NorthShore University HealthSystem
Evanston, Illinois, 60201
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Scripps Memorial Hospital/Scripps Green Hospital
La Jolla, California, 92037
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33136
Intermountain Medical Center
Murray, Utah, 84157
Ochsner Clinic
New Orleans, Louisiana, 70121
New York Presbyterian Hospital - Cornell
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic-Saint Marys Hospital
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98101
Barnes-Jewish/Washington University
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada3 sites
Laval Hospital
Québec, G1V 4G5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver St. Paul's
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
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.
Read the detailed description
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
- Critical Aortic Stenosis
- Being tested
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Keywords
- Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards SAPIEN Transcatheter Heart ValveDevice
Surgical Valve ReplacementDevice
medical management and/or balloon aortic valvuloplastyOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cohort A: Sapien Valve Receives: Device: Edwards SAPIEN Transcatheter Heart Valve |
| 2 | Active comparator | Cohort A: other surgical valve Receives: Device: Surgical Valve Replacement |
| 3 | Experimental | Cohort B: Sapien Valve Receives: Device: Edwards SAPIEN Transcatheter Heart Valve |
| 4 | Active comparator | Cohort B: Medical therapy Receives: Other: medical management and/or balloon aortic valvuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from any cause.
Measured: 1 Year
Composite of Death and Recurrence Hospitalization.
Death from any cause or repeat hospitalization after intervention.
Measured: duration of study
Secondary outcomes (4)
Functional Change of NYHA
NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Measured: Baseline to 1 year
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Measured: 1 year
Total Hospital Days From the Index Procedure
Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Measured: 1 year
Change in Quality of Life (QOL) From Baseline to 1 Year
The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.
KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.
SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
Measured: Baseline and 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2010
- Study completionJul 2017
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 (59)Papers the sponsor has linked to this study.
- Other trials for Critical 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
- 1,057 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, New York-Presbyterian Hospital/Columbia University Medical CenterCraig Smith, MD, Principal investigator, New York-Presbyterian Hospital/Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530894
- Sponsor's protocol ID
- 2006-06-US
- Acronym
- PARTNER
- Status last verified
- Aug 2017
- First submitted
- 14 Sep 2007
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36538580Shahim 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 35656983Vincent 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 35041482Summers 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 31690104Kapadia 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.
PubMed 30442284Elmariah 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.
PubMed 29217004Douglas 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.
PubMed 28973520Lindman 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.
PubMed 28701528Beohar 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.
PubMed 28467527Daubert 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.
PubMed 28017714Kapadia 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.
PubMed 27601428Anjan 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.
PubMed 27437665Suri 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.
PubMed 27215927Kodali 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.
PubMed 26903039Beohar 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.
PubMed 26803420
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
- ClinicalTrials.gov ID
- NCT00530894
- Acronym / sponsor ID
- PARTNER / 2006-06-US
- Conditions
- Critical Aortic Stenosis
- Keywords
- Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2007 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Posted 11 May 2017
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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Edwards SAPIEN Transcatheter Heart ValveCohort A: Sapien Valve |
| 2 | Active comparator | Device: Surgical Valve ReplacementCohort A: other surgical valve |
| 3 | Experimental | Device: Edwards SAPIEN Transcatheter Heart ValveCohort B: Sapien Valve |
| 4 | Active comparator | Other: medical management and/or balloon aortic valvuloplastyCohort B: Medical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
- 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
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Key exclusion criteria (5 listed)
- Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- 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).
- Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
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 Transcatheter Heart Valve | Device | 1, 3 |
| Surgical Valve Replacement | Device | 2 |
| medical management and/or balloon aortic valvuloplasty | Other | 4 |
Primary outcome
Death
Time frame: 1 Year
Death from any cause.
Composite of Death and Recurrence Hospitalization.
Time frame: duration of study
Death from any cause or repeat hospitalization after intervention.
4 secondary outcomes
Functional Change of NYHA
Time frame: Baseline to 1 year
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Time frame: 1 year
Total Hospital Days From the Index Procedure
Time frame: 1 year
Change in Quality of Life (QOL) From Baseline to 1 Year
Time frame: Baseline and 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36538580Huded 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.
- 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 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 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.
- Derived from this study: PubMed 30442284Kapadia 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.
- Derived from this study: PubMed 29217004Elmariah 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.
- Derived from this study: PubMed 28973520Douglas 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.
- Derived from this study: PubMed 28701528Lindman 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.
- Derived from this study: PubMed 28467527Beohar 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.
- Derived from this study: PubMed 28017714Daubert 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.
- Derived from this study: PubMed 27601428Kapadia 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.
- Derived from this study: PubMed 27437665Anjan 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.
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Cardiomyopathies, Amyloidosis Cardiac
RecruitingObservational study
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
Congenital Heart Disease, Coarctation of Aorta
Active, not recruiting
The Nordic Aortic Valve Intervention Trial
Critical Aortic Stenosis
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
New York-Presbyterian Hospital/Columbia University Medical Center
Craig Smith, MD principal investigator
New York-Presbyterian Hospital/Columbia University Medical Center
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement and medical management and/or balloon aortic valvuloplasty in people with Critical Aortic Stenosis, run by Edwards Lifesciences at 26 sites in 3 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 7 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, Germany. 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 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530894, which also lists 59 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 13 Sep 2017.