TandemHeart to Reduce Infarct Size (TRIS Trial)

Status:	Recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	11/28/2015
Start Date:	January 2015
End Date:	February 2017
Contact:	Kristie A Burgess, PhD
Email:	kburgess@tandemheart.com
Phone:	412-963-7770

A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size

The purpose of this study is to determine if a device known as the TandemHeart® System
(TandemHeart) can help limit heart damage and reduce serious complications after a certain
type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by
evaluating the use of the TandemHeart system prior to a procedure called percutaneous
coronary intervention (PCI)

INCLUSION CRITERIA

The following is a list of general inclusion criteria. More detailed information can be
found in the study protocol.

1. ≥ 18 years of age

2. Presents within 6 hours of acute MI symptoms

3. Evidence of ST elevation

4. First myocardial infarction

5. Written informed consent

EXCLUSION CRITERIA

The following is a list of general exclusion criteria. More detailed information can be
found in the study protocol.

1. Contraindications to antiplatelet/anticoagulation therapy

2. History of blood disorders or active bleeding

3. Renal dysfunction or failure

4. Neurologic damage

5. Cardiogenic shock

6. History of cerebrovascular disease

7. History of transfusion reaction

8. Prior coronary artery bypass surgery

9. Participation in another trial with an investigational drug or device

10. Pregnant

We found this trial at

sites

Allegheny General Hospital

320 E North Ave
Pittsburgh, Pennsylvania 15212

(412) 359-3131