Maryland Heart Center

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

Referring Physician Information

Clinical Trial for PARTNER II

The TAVR Procedure

Courtesy of Edwards Lifesciences

What is the PARTNER II Trial?

The PARTNER II Trial is a multicenter investigational study that will evaluate the safety and effectiveness of transcatheter aortic valve replacement using the 2nd generation Edwards SAPIEN XT tissue valve and NovaFlex delivery system.

The device and delivery system will be evaluated in high-risk patients with severe aortic stenosis. All patients enrolled in the PARTNER II Trial will undergo transcatheter valve replacement.

For a complete list of inclusion and exclusion criteria, visit: http://clinicaltrials.gov/ct2/show/NCT01314313

How does the SAPIEN XT (2^nd generation) valve differ from the Edwards SAPIEN valve used in the original PARTNER trial?

The SAPIEN XT design has a lower profile (smaller), which allows for more controlled, precise placement. The SAPIEN XT is also being tested for increased durability. The new design will allow a broader spectrum of patients to be treated with fewer vascular complications.

What is the process for patients to be evaluated for the trial?

After physicians refer patients to UMMC for the trial, the patient will be scheduled for a thorough evaluation in our multidisciplinary clinic. There, patients will undergo the appropriate screening tests (such as ECHO, EKG or CT scan) and will be evaluated by a cardiologist, two cardiac surgeons and nurse practitioner. After additional consultation from the trial committee, the referring physician and patient will be informed of the patient’s enrollment status.

How is the referring physician kept informed of patient care and progress during the trial?

The physicians in the Heart Valve Program at the University of Maryland will keep referring physicians informed about the patients referred here for care. Referring physicians are part of the team and will remain involved in treatment plans to foster the best long-term outcomes for each patient.

After the patient has been evaluated, UMMC will notify the referring physician about the patient’s enrollment status. Once the patient is enrolled in the trial, the referring physician will be regularly updated on the patient’s progress. Referring physicians are encouraged to contact a member of the trial team at any time to discuss a patient’s treatment plan.

Enrolled patients will undergo clinical follow-up at discharge, 30 days, six months, 12 months, and annually thereafter to a minimum of five years post-procedure. During this time, the patient will receive coordinated care from their PCP or primary cardiologist and University of Maryland physicians.

What is the cost to the patient?

There is no cost to the patient for participation in PARTNER II. However, the patient will be required to provide transportation to and from appointments for evaluation and consultation before and after surgery.

Patient Responsibilities

Initial evaluation time will vary, but patients should plan on spending at least four hours for the first initial evaluation in the Heart Valve clinic. Patients will receive an echocardiogram and will be evaluated by a cardiologist, a cardiac surgeon and the research team. Additional testing may also be requested from the clinical team during that initial evaluation.

Following the initial evaluation, patients will be required to return to the clinic for a follow-up visit for additional research procedures that are required at specific times prior to the procedure date.

The length of hospital stay following the procedure will vary depending on each patient’s condition. Average length of stay is approximately seven days and tends to be shorter than the average stay for open heart surgery.

Patients will be required to attend follow-up appointments in the Heart Valve clinic at 30 days, six months, and one year after the procedure, and then on a yearly basis for up to five years. The follow-up testing will take approximately an hour and a half per visit and is a crucial part of the research protocol.

If a patient is not eligible for the trial, what alternative therapies can the University of Maryland offer?

The University of Maryland Heart Valve Program offers several treatment options for patients with symptomatic aortic stenosis, including patients who are otherwise inoperable.

In addition the PARTNER II Clinical Trial and traditional open heart surgeries, we also offer minimally invasive options, including:

Aortic valve replacement and repairs
Aortic valve bypass
Balloon aortic valvuloplasty

If a patient is ineligible for the trial and would like information on alternative therapies, we can discuss alternative therapies and long-term care with the patient and their referring physician.

How can I receive more information about or refer my patient to the PARTNER II Trial?

For more information or to refer a patient, please call: 410-32-VALVE (410-328-2583)

Cardiology:

David A. Zimrin M.D.
Principal Investigator
Assistant Professor of Medicine

Anuj Gupta, M.D.
Assistant Professor of Medicine

Gautam V. Ramani, M.D.
Assistant Professor of Medicine

Anesthesiology:

Patrick N. Odonkor, M.B., Ch.B.
Assistant Professor of Anesthesiology
Interim Director of Cardiothoracic Anesthesiology

Cardiac Surgery:

Bartley Griffith, M.D.
Principal Investigator
Professor of Surgery

James S. Gammie, M.D.
Associate Professor of Surgery

Teng C. Lee, M.D.
Assistant Professor of Surgery

Eligibility Criteria for Cohort B (inoperable)

Genders Eligible for Study: Both
Accepts Health Volunteers: No

Criteria

Inclusion:

Patient has severe aortic valve stenosis per echo: mean gradient >40 mmHg or jet velocity greater than 4.0m/s and an aortic valve area of <0.8 cm2 or indexed EOA <0.5 cm2/m2
NYHA≥ 2
Probability of death or serious, irreversible morbidity > 50%
Patient or patient's legal representative has been informed of the nature of the study and has provided written informed consent

Exclusion:

MI ≤1 month before treatment
Congenital unicuspid or bicuspid aortic valve or non-calcified aortic valve
Mixed aortic valve disease
Cardiac procedure resulting in a permanent implant performed within 30 days of the procedure or within 6 months if drug eluting coronary stent implanted
Severe mitral insufficiency
Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis or coagulopathy
Untreated clinically significant coronary artery disease
Hemodynamic or respiratory instability within 30 days of screening
Need for emergency surgery
Hypertrophic cardiomyopathy
Severe ventricular dysfunction
ECHO evidence of intracardiac mass, thrombus or vegetation
Active peptic ulcer or active GI bleeding within 3 months prior to procedure
A known contraindication to anticoagulation or inability to be anticoagulated for the study procedure
Native aortic annulus size <18mm or >25mm
CVA, TIA or cluster within 6 months of the procedure
Renal insufficiency and/or end-stage renal disease requiring dialysis at the time of screening
Estimated life expectancy <12 months due to non-cardiac conditions
Significant aortic disease, such as abdominal aortic or thoracic aneurysm, marked tortuosity, aortic arch atheroma
Illiofemoral vessel characteristics that would preclude safe placement of the study introducer sheath such as severe obstructive calcification, severe tortuosity or vessels size
Participating in an investigational drug or another device study
Enrolled in PARTNER I or withdrawn from the PARTNER I prior to endpoint analysis
Active endocarditis or other active infections within 6 months of procedure
Bulky calcified aortic valve leaflets in close proximity to coronary ostia

Please call if you would like to make an appointment or talk to someone about our services. Patients dial 1-866-408-6885, physicians dial 410-328-6622 or 1-800-318-1019.