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TandemHeart to Reduce Infarct Size (TRIS Trial) (TRIS)

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ClinicalTrials.gov Identifier: NCT02164058
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : June 16, 2014
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: TandemHeart System Procedure: Percutaneous coronary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
Study Start Date : January 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: TandemHeart System + PCI
TandemHeart System prior to percutaneous coronary intervention
Device: TandemHeart System
Procedure: Percutaneous coronary intervention
Other Name: PCI

Active Comparator: PCI
Percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Other Name: PCI




Primary Outcome Measures :
  1. Primary Safety [ Time Frame: 30 days post-procedure ]

    Major Adverse Cardiac or Cerebrovascular Events (MACCE):

    • Death, all cause
    • Stroke
    • Reinfarction
    • Major vascular complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: CardiacAssist, Inc.
ClinicalTrials.gov Identifier: NCT02164058     History of Changes
Other Study ID Numbers: CA 2011-01
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by CardiacAssist, Inc.:
Myocardial infarction
STEMI
ST elevation MI
Acute MI
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases