Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Medtronic

Status: Enrolling

Conditions: Cardiovascular Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT04241328

MDT19022PMF001

Details and patient eligibility

About

The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

Full description

The objective is to collect product safety and performance data for Medtronic CE (Conformitè Europëenne )-Marked Cardiac Surgery, including perfusion (CS) products.

The main goals of this data collection are as follows:

• Identification of any (new) device-related complications including events which were not anticipated or documented in the Instructions For Use (IFU), or Risk Management Plan, or Clinical Evidence Evaluation report, or Design Failure Modes and Effect Analysis
• Evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies
• Evaluation of general device performance when applicable

Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital.

Inclusion Criteria:

• Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating Registry hospital.
• Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.

Exclusion Criteria:

• Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry

Data collection includes, for example:

• Demographics
• Product performance information
• Safety Events

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital.
• Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.

Exclusion criteria

• Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry