The Columbia Heart Valve Center is currently enrolling patients in the PARTNER II Trial (Placement of AoRTic TraNscathetER Valves). There are two parallel arms to this clinical trial.
The first arm of the study is for patients who are considered "intermediate-risk" for surgery. Patients who do not have femoral access will be treated with either the transapical approach (a small incision just under the left chest ) or the transaortic (direct access to the aorta via a small incision on the top portion of the breast bone) approach.
The second arm of the PARTNER II Trial is evaluating the following:
- Valve-in-valve TAVR, an approach in which a transcather valve replacement is performed for a deteriorating, surgically implanted aortic bioprosthetic valve. The new valve is implanted tightly inside the failing valve. This is be examined in inoperable patients.
- The smaller, next generation device for patients with small vessels whose anatomy cannot accommodate the current device size. This is being examined in patients who are inoperable or high risk for surgery.
Process to Enroll
Once you are evaluated by our heart team and it is determined that you meet both the risk and anatomical criteria for the clinical trial, the following steps will take place:
- You will meet with a clinical research coordinator or a physician assistant to discuss the consent form. You will have the opportunity to take the consent form with you to review it with family and friends. You will be provided with the name and contact number of an experienced member of our team to whom you can address questions. If you agree to participate in the trial, you must sign the consent form.
- Next, you will need to have a “baseline assessment” which will evaluate how you are currently impacted by your valve disease. The baseline assessment includes a 6-minute walking test, a survey to determine the severity of your symptoms (KCC Questionnaire), a mental acuity examination, a chest x-ray, and blood-work.
If you are enrolled in the trial, we will conduct post-procedural assessments to evaluate your improvement over a period of time. You will be required to return to the hospital 30 days, six months, and one year post-procedure, and annually five years for follow-up care. At each follow-up appointment, one or more of the assessment tests will be repeated.
- Upon completion of steps one and two, a procedure date will be scheduled.
For further information contact Marian Hawkey at 212-342-0444.