THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00530894
First received: September 14, 2007
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Critical Aortic Stenosis
Device: Edwards SAPIEN Transcatheter Heart Valve
Device: Surgical Valve Replacement
Other: medical management and/or balloon aortic valvuloplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Freedom from death (Cohort A: Edwards Sapien Valve{Transfemoral or Transapical} vs. other surgical valve) [ Time Frame: 1 year ]
  • Freedom from Death (Cohort B: Edwards Sapien Valve{transfemoral} vs. medical therapy) [ Time Frame: duration of study ]

Secondary Outcome Measures:
  • Functional Improvement from baseline per NYHA functional classification (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, 1 year ]
  • Freedom from MACCE and expanded safety composite events. [ Time Frame: 30 days, 6 months, 1 year ]
  • Evidence of prosthetic valve dysfunction (hemolysis, infection, thrombosis, severe paravalvular leak, or migration) (Cohort A) [ Time Frame: 30 days, 6 months, 1 year ]
  • Length of index hospital stay (Cohort A) [ Time Frame: number of days hospitalized ]
  • Total hospital days from the index procedure to one year post procedure. (Cohort A) [ Time Frame: 1 year ]
  • Improved Quality of Life (QOL) from baseline to 30 days, 6 months, and annually through year 5 (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, years 1 - 5 ]
  • Improved valve function demonstrated by a responder analysis showing the percentage of patients in each treatment group who have a greater than 50% improvement in AVA at 30 days, 6 months, and 12 months. (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, 1 year ]
  • Total hospital days from the index procedure or randomization in to control arm for medical management patients to 1 year post procedure or randomization (Cohort B) [ Time Frame: 1 year ]
  • Composite of survival, recurrent hospitalization and NYHA class.

Estimated Enrollment: 3285
Study Start Date: April 2007
Estimated Study Completion Date: March 2017
Arms Assigned Interventions
Experimental: 1
Cohort A: Sapien Valve
Device: Edwards SAPIEN Transcatheter Heart Valve
Active Comparator: 2
Cohort A: other surgical valve
Device: Surgical Valve Replacement
Experimental: 3
Cohort B: Sapien Valve
Device: Edwards SAPIEN Transcatheter Heart Valve
Active Comparator: 4
Cohort B: Medical therapy
Other: medical management and/or balloon aortic valvuloplasty

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Cohort A

  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%.

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
  6. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
  7. Untreated clinically significant coronary artery disease requiring revascularization
  8. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  9. Need for emergency surgery for any reason
  10. Hypertrophic cardiomyopathy with or without obstruction
  11. Severe ventricular dysfunction with LVEF <20
  12. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  13. Active peptic ulcer or upper GI bleeding within the prior 3 months
  14. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
  15. Native aortic annulus size < 16mm or > 24mm per the baseline echo as estimated by the LVOT
  16. Patient has been offered surgery but has refused surgery.
  17. Recent (within 6 months) CVA or a TIA
  18. Renal insufficiency and/or end stage renal disease requiring chronic dialysis
  19. Life expectancy < 12 months due to non-cardiac co-morbid conditions.
  20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta(applicable for transfemoral patients only).
  21. Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F introducer sheath such as severe obstructive calcification, severe tortuosity or vessels size less than 7 mm in diameter(applicable for transfemoral patients only).
  22. Currently participating in an investigational drug or another device study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530894

  Show 26 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Martin B Leon, MD New York-Presbyterian Hospital/Columbia University Medical Center
Principal Investigator: Craig Smith, MD New York-Presbyterian Hospital/Columbia University Medical Center
  More Information

No publications provided by Edwards Lifesciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00530894     History of Changes
Other Study ID Numbers: 2006-06-US
Study First Received: September 14, 2007
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada

Keywords provided by Edwards Lifesciences:
Valvular Heart Disease
Critical/Severe Aortic Stenosis
High risk symptomatic patients

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 19, 2014