TandemHeart to Reduce Infarct Size (TRIS Trial)

CardiacAssist, Inc.

Status: Withdrawn

Conditions: Acute Myocardial Infarction

Treatments: Device: TandemHeart System; Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02164058

CA 2011-01

Details and patient eligibility

About

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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TandemHeart System + PCI

Experimental group

Description:

TandemHeart System prior to percutaneous coronary intervention

Treatment:

Device: TandemHeart System

Procedure: Percutaneous coronary intervention

PCI

Active Comparator group

Description:

Percutaneous coronary intervention

Treatment:

Procedure: Percutaneous coronary intervention