A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- CardiacAssist, Inc.
- Primary Endpoint
- Primary Safety
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TandemHeart System + PCI
TandemHeart System prior to percutaneous coronary intervention
Intervention: TandemHeart System (Device)
TandemHeart System + PCI
TandemHeart System prior to percutaneous coronary intervention
Intervention: Percutaneous coronary intervention (Procedure)
PCI
Percutaneous coronary intervention
Intervention: Percutaneous coronary intervention (Procedure)
Outcomes
Primary Outcomes
Primary Safety
Time Frame: 30 days post-procedure
Major Adverse Cardiac or Cerebrovascular Events (MACCE): * Death, all cause * Stroke * Reinfarction * Major vascular complications
Secondary Outcomes
No secondary outcomes reported