PSR MCS Base protocol V3
Research type
Research Study
Full title
Mechanical Circulatory Support (MCS) Product Surveillance Registry(PSR) - Platform Base CIP Version 3
IRAS ID
268976
Contact name
Stefan Schueler
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 7 months, 3 days
Research summary
The registry has been designed as a framework, entitled the "Base Protocol", comprising minimum standards and criteria into which individual therapy specific investigation plans will be incorporated, indefinately, over time. Within this framework, participants are to be managed under routine care, enabling product performance and patient outcomes to be assessed in a "real life" environment. The duration of data collection will be determined by the product received by the patient, but will normally be no less than one year and may extend to several years as defined within each therapy specific investigation plan.
The current submission includes the overall Base Protocol for the registry and additionally the protocol for patients who have received, or are due to receive, a Medtronic Mechanical Cirulatory Support product or Medtronic component of such
a system. Following the implant procedure, the patient will return for clinic visits according to the hospital schedule.
Registry data will be derived from routine followup records until either the sponsor determines that data collection is sufficient, the system is no longer active in the body, or the patient is exited for another reason.
Over time the registry will create extensive repository of data to serve as a
source of information relating to acute and chronic product performance, patient safety and clinical outcomes. Such data may assist with the early detection of product performance issues and help to define patient outcomes with the
aim of creating benefits for patients through future advances in technology and condition management.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0360
Date of REC Opinion
3 Jan 2020
REC opinion
Unfavourable Opinion