TandemHeart to Reduce Infarct Size (TRIS Trial)

Acute Myocardial Infarction Clinical Trial

— TRIS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02164058
• Other study ID #: CA 2011-01
• Status: Withdrawn
• Phase: N/A
• First received: June 12, 2014
• Last updated: December 3, 2015
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: December 2015
• Source: CardiacAssist, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• TandemHeart System

Procedure:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CardiacAssist, Inc.

Outcome

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