TandemHeart to Reduce Infarct Size (TRIS Trial) | NCT02164058

Studies
TandemHeart to Reduce Infarct Size (TRIS Trial)

NCT02164058

Sponsor

CardiacAssist, Inc.

Status

Withdrawn

Last Update Posted

Dec 4, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

TandemHeart System
Percutaneous coronary intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jun 12, 2014

First Posted Date

Jun 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2015

Last Update Posted Date

Dec 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TandemHeart System + PCI	Experimental	TandemHeart System prior to percutaneous coronary intervention	Device: TandemHeart System Procedure: Percutaneous coronary intervention
PCI	Active Comparator	Percutaneous coronary intervention	Procedure: Percutaneous coronary intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TandemHeart System	Device		TandemHeart System + PCI
Percutaneous coronary intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.

≥ 18 years of age
Presents within 6 hours of acute MI symptoms
Evidence of ST elevation
First myocardial infarction
Written informed consent

EXCLUSION CRITERIA

The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.

Contraindications to antiplatelet/anticoagulation therapy
History of blood disorders or active bleeding
Renal dysfunction or failure
Neurologic damage
Cardiogenic shock
History of cerebrovascular disease
History of transfusion reaction
Prior coronary artery bypass surgery
Participation in another trial with an investigational drug or device
Pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062645	Percutaneous Coronary Intervention

Ancestor Terms

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided