TandemHeart to Reduce Infarct Size (TRIS Trial)

Not Applicable

Withdrawn

• Conditions: Acute Myocardial Infarction
• Interventions: Device: TandemHeart System; Procedure: Percutaneous coronary intervention

• Registration Number: NCT02164058
• Lead Sponsor: CardiacAssist, Inc.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Study Start: 2015-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04
• Primary Completion: 2016-08
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TandemHeart System + PCI	Percutaneous coronary intervention	TandemHeart System prior to percutaneous coronary intervention
PCI	Percutaneous coronary intervention	Percutaneous coronary intervention
TandemHeart System + PCI	TandemHeart System	TandemHeart System prior to percutaneous coronary intervention

Primary Outcome Measures

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