TandemHeart to Reduce Infarct Size (TRIS Trial)

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02164058

Acronym

TRIS

Enrollment

Registered

2014-06-16

Start date

2015-01-31

Completion date

2017-02-28

Last updated

2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Myocardial infarction, STEMI, ST elevation MI, Acute MI

Brief summary

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)

Interventions

DEVICETandemHeart System

PROCEDUREPercutaneous coronary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Safety	30 days post-procedure	Major Adverse Cardiac or Cerebrovascular Events (MACCE): * Death, all cause * Stroke * Reinfarction * Major vascular complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026