An Evolut™ EXPAND TAVR II Pivotal Trial

Overview

About this study

The purpose of this study is to obtain safety and effectiveness data to support indication expansion for the Medtronic transcatheter aortic valve replacement (TAVR) System to include patients with moderate, symptomatic Aortic Stenosis (AS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Moderate AS, defined as follows by transthoracic echo (TTE) at rest:

- Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec; and

- Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg; and

- AVA > 1.0 cm^2 and < 1.5 cm^2.

- NYHA class ≥ II and symptoms of AS, including but not limited to:

- Dyspnea at rest or on exertion;

- Fatigue;

- Angina;

- Syncope in the absence of another identifiable cause;

- LVEF > 20% by 2-D echo.

- Any of the following:

- HF event or hospitalization within 1 calendar year prior to qualifying echo;

- NT proBNP ≥ 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior to or
within 2 weeks after qualifying echo;

- Global longitudinal strain ≤ 15% (absolute value) at qualifying echo; or

- E/e' (average of medial and lateral velocities) ≥ 14.0 at qualifying echo.

Exclusion Criteria:

- Age < 65 years

- Class I indication for cardiac surgery.

- Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve
with ascending aorta diameter > 4.5 cm.

- Not anatomically suitable for transfemoral TAVR.

- In need of and suitable for coronary revascularization per Heart Valve Team.

- Documented history of cardiac amyloidosis.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available