THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

Critical Aortic Stenosis Clinical Trial

— PARTNER  

Official title:

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00530894
• Other study ID #: 2006-06-US
• Status: Active, not recruiting
• Phase: N/A
• First received: September 14, 2007
• Last updated: February 7, 2014
• Start date: April 2007
• Est. completion date: March 2017

Study information

• Verified date: February 2014
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3285
• Est. completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Critical Aortic Stenosis

Intervention

Device:
• Edwards SAPIEN Transcatheter Heart Valve

• Surgical Valve Replacement

Other:
• medical management and/or balloon aortic valvuloplasty

Locations

Country	Name	City	State
Canada	Laval Hospital	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver St. Paul's	Vancouver	British Columbia
Germany	Heart Center Leipzig	Leipzig
United States	Emory University Hospital	Atlanta	Georgia
United States	Boston Mass General	Boston	Massachusetts
United States	Brigham and Women's	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical City Dallas	Dallas	Texas
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Scripps Memorial Hospital/Scripps Green Hospital	La Jolla	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Intermountain Medical Center	Murray	Utah
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	New York Presbyterian Hospital - Cornell	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic-Saint Marys Hospital	Rochester	Minnesota
United States	University of Washington	Seattle	Washington
United States	Barnes-Jewish/Washington University	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	Washington Hospital Center	Washington DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from death (Cohort A: Edwards Sapien Valve{Transfemoral or Transapical} vs. other surgical valve)		1 year
Primary	Freedom from Death (Cohort B: Edwards Sapien Valve{transfemoral} vs. medical therapy)		duration of study
Secondary	Functional Improvement from baseline per NYHA functional classification (Cohort A and Cohort B)		30 days, 6 months, 1 year
Secondary	Freedom from MACCE and expanded safety composite events.		30 days, 6 months, 1 year
Secondary	Evidence of prosthetic valve dysfunction (hemolysis, infection, thrombosis, severe paravalvular leak, or migration) (Cohort A)		30 days, 6 months, 1 year
Secondary	Length of index hospital stay (Cohort A)		number of days hospitalized
Secondary	Total hospital days from the index procedure to one year post procedure. (Cohort A)		1 year
Secondary	Improved Quality of Life (QOL) from baseline to 30 days, 6 months, and annually through year 5 (Cohort A and Cohort B)		30 days, 6 months, years 1 - 5
Secondary	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)		30 days, 6 months, 1 year
Secondary	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)		1 year
Secondary	Composite of survival, recurrent hospitalization and NYHA class.