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Medtronic Resting Heart Bypass System

Phase 1

Coronary Artery Bypass Surgery | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Aug 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Medtronic Resting Heart Bypass System · 1 trial · 2 indications

Phase 1 1
NCT00303641Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery PatientsCoronary Artery Bypass Surgery
COMPLETED60 Analytics
PHASE1COMPLETED
Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients
Coronary Artery Bypass SurgeryUnlock trial analytics

Study Endpoints

Primary Endpoints

C-reactive protein
Cell count
Cytokine levels
Complement

Secondary Endpoints

Postoperative blood loss, units of blood transfused, re-operation for bleeding, chest tube drainage, length of ICU stay, neurologic and renal function, infection, atrial fibrillation and overall length of postoperative hospital stay
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Medtronic Resting Heart Bypass SystemDEVICE -
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Eligibility Criteria

Age Range30 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Consenting patients undergoing elective surgical coronary artery bypass grafting (CABG) with use of the cardiopulmonary bypass machine Exclusion Criteria: * Patients unable to provide written informed consent * Emergency CABG surgery * Concomitant CABG + Valvular surgery * O...

Countries:Canada
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Frequently asked questions about Medtronic Resting Heart Bypass System

What is the Medtronic Resting Heart Bypass System used for?

The Medtronic Resting Heart Bypass System is used for coronary artery bypass surgery. It is a device designed for use in heart surgery patients, specifically to facilitate bypass procedures while potentially avoiding the need for cardiopulmonary bypass. It is currently in Phase 1 clinical development.

Who makes the Medtronic Resting Heart Bypass System?

The Medtronic Resting Heart Bypass System is developed by Medtronic plc, a medical device company traded on the New York Stock Exchange under the ticker symbol MDT. The system is being evaluated for use in coronary artery bypass surgery.

What phase is the Medtronic Resting Heart Bypass System in?

The Medtronic Resting Heart Bypass System is in Phase 1 clinical development. It is an investigational device, not yet approved for commercial use. One Phase 1 trial has been completed, involving 60 participants in Canada.

What clinical trials is the Medtronic Resting Heart Bypass System in?

The Medtronic Resting Heart Bypass System has one completed clinical trial, registered as NCT00303641. The trial, titled 'Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients,' was a Phase 1 study with 60 participants in Canada.

Is the Medtronic Resting Heart Bypass System FDA approved?

The Medtronic Resting Heart Bypass System is not FDA approved. It is an investigational device currently in Phase 1 clinical development. A single Phase 1 trial has been completed, but the device has not yet received regulatory approval for commercial use.