Indication Extension for Medical Devices Using RWE from NESTcc Network Collaborators: Safety and Effectiveness of Cardiac Ablation of Persistent Atrial Fibrillation and Ischemic Ventricular Tachycardia Using Thermocool Catheters (NESTcc TC07 Phase 2)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  Electronic Health Records (EPIC) generated from Mercy and Mayo Health Systems

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No

Procedures

Procedure of results generation

ThermoCool NEST Study Label Extension SAP_20July2021_authorized