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)

Study identification

• EU PAS number:
  EUPAS39629
• Study ID:
  43262
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The NESTcc Test Case 07 titled “The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters,” was completed as of March 2020. This study is a follow-up study on the same medical devices and area of research as the initial feasibility study and would provide the opportunity to translate the advances and lessons learned in the feasibility study into an actual label expansion study that will be submitted to the FDA CDRH Office of Health Technology 2 (Electrophysiology). The specific aims are to use retrospective real-world data from the EHR systems at Mercy and Mayo Clinic to evaluate the safety and effectiveness of ablation for 1) persistent AF and 2) ischemic VT using ThermoCool catheters.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Mercy Healthcare System

Mayo Clinic Rochester, MN

Networks

NESTcc

Study timelines

Date when funding contract was signed

Planned:01/07/2020

Actual:01/07/2020

Study start date

Planned:14/05/2021

Actual:28/05/2021

Data analysis start date

Actual:04/06/2021

Date of final study report

Planned:31/08/2022

Sources of funding

Other

More details on funding

Medical Device Innovation Consortium

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable