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TandemHeart to Reduce Infarct Size (TRIS Trial)

NCT ID: NCT02164058

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-02-28

Brief Summary

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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)

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TandemHeart System + PCI

TandemHeart System prior to percutaneous coronary intervention

Group Type EXPERIMENTAL

TandemHeart System

Intervention Type DEVICE

Percutaneous coronary intervention

Intervention Type PROCEDURE

PCI

Percutaneous coronary intervention

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type PROCEDURE

Interventions

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TandemHeart System

Intervention Type DEVICE

Percutaneous coronary intervention

Intervention Type PROCEDURE

Other Intervention Names

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PCI

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardiacAssist, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CA 2011-01

Identifier Type: -

Identifier Source: org_study_id