TandemHeart to Reduce Infarct Size (TRIS Trial)

CardiacAssist, Inc.

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Myocardial Infarction

Interventions

TandemHeart SystemDEVICE

Percutaneous coronary interventionPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Safety

Major Adverse Cardiac or Cerebrovascular Events (MACCE): * Death, all cause * Stroke * Reinfarction * Major vascular complications

Time frame: 30 days post-procedure

Data from ClinicalTrials.gov

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