»Cardiovascular Clinical Trials 

Protocol
            
806816

Title
            
PARTNER Trial: Placement of Aortic Transcatheter Valves

Investigator
            
Joseph Bavaria, MD

Status
            
Recruiting

Why is this study being done?
            
The purpose of this study is to determine the safety and effectiveness of the Edwards SAPIEN Transcatheter Heart Valve device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

Device website: http://www.edwards.com/Products/TranscatheterValves/SapienTHV.htm


Who is eligible to participate in this study?
            Inclusion
This study is for high risk patients with critical aortic stenosis who meet the inclusion/exclusion criteria. Below only highlights the major inclusion and exclusion criteria. There are 2 major groups in this trial, cohort A and cohort B.

The first group will be high risk surgical subjects group (Group A) and the second group will be a non-surgical subject group (Group B). The high risk surgical subject group, group A, means that based on the opinion of a cardiothoracic surgeon and a cardiologist you have a greater than or equal to 15% risk of death if you were to have your valve replaced through a traditional (open-chest) surgical procedure. Non-surgical subject group (best medical management group), group B, means that based on the opinion of two cardiothoracic surgeons and a cardiologist you have a greater than or equal to 50% risk of death or serious, irreversible complications if you were to have your valve replaced through a traditional open-chest surgical procedure. Your physician believes that this level of risk rules you out for a traditional open-chest surgical replacement of your valve. The high risk surgical subject group (Group A) will then be divided into three smaller groups. One group will receive the transcatheter procedure through the artery (blood vessel) in the leg (this is the transfemoral group). Another group will receive the transcatheter procedure through an incision in the chest (this is the transapical group). The third group will undergo conventional (open-chest) aortic valve replacement therapy.

Based on the results of your screening tests, you have been assigned to one of the following groups: High Risk Surgical Subject Group (Group A) or Non-Surgical Subject Group (Group B).

Once the patient has been assigned to group and has enrolled in the trial the patient is than randomized into the test or control group.

  • The echocardiogram shows a critical valve area and demonstrates an appropriate size for placement of the study valve.
  • The patient is considered a high risk surgical candidate and is evaluated using the Society of Thoracic Surgical risk calculator as well as assessing other risk factors that would deem a patient a high surgical risk.
  • The patient signs the informed consents and agrees to participate by the protocol of the trial.
            Exclusion
  • The patient cannot have other severe valvular disease.
  • The patient cannot have had previous valve surgery.
  • Any major adverse event must be evaluated and the appropriate time to wait for implant must be observed as noted in the protocol.
  • The patient must have a greater than 1 year life expectancy.
  • The patient cannot be participating in another clinical drug or device trial.

Age range?
            From:
None

What is involved with this study?
            
A catheter carrying a bio-prosthetic valve as wide as a pencil is threaded up the femoral artery (a vein in the leg) or via a small incision in the chest (small thoracotomy), to the aortic valve, where it positions the new valve over the damaged one.

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.

Pre-Op:
The patient will be asked to complete a screening for enrollment which includes all standard-of-care pre-operative studies.

Non-standard of care studies include:
CT scan of the vessels in the legs and abdomen with a possible aortogram (catheterization of the lower extremities), specific blood studies that evaluate breakdown of blood cells, quality of life survey, 6-minute walk test and a neurological evaluation.

Post-Op:
Follow-ups at 1 month, 6 months, 1 year and annually thereafter. It includes an examination, echocardiogram, chest x-ray, ECG, blood work, quality of life survey, 6-minute walk test and a neurological exam.

More Information at ClinicalTrials.gov
http://clinicaltrials.gov/ct2/show/NCT00530894?term=bavaria&recr=Open&state1=NA%3AUS%3APA&rank=2


How long will this study run?
            
This study will run for approximately 5 years.

Who can I contact for additional information on this trial?
            Name:
Lisa Walsh, RN, RN, MS
            Phone:
215-662-4289
            Email:
lisa.walsh@uphs.upenn.edu
            Name:
Virginia Blaskovich, RN, CCRC
            Phone:
215-662-4289
            Email:
virginia.blaskovich@uphs.upenn.edu
            Web Site:
http://www.uphs.upenn.edu/surgery/faculty/jeb.html
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