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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  1050

Study design details

• Main study objective:
  Objective 1: demonstrate safety and effectiveness of ablation with ThermoCool ST catheters for treatment of persistent AF in real-world settings supporting label expansions of these catheters. Objective 2: demonstrate safety and effectiveness of ablation with ThermoCool STSF catheters for treatment of ischemic VT in real-world settings supporting label expansions of these catheters.
• Outcomes:
  Persistent AF: Primary safety endpoint is the cumulative incidence of a composite of primary adverse events (PAEs) occurring within 7 days of the initial and repeat ablation using ST catheter Ischemic VT: Primary safety endpoint is the cumulative incidence of a composite of cardiovascular-specific adverse events (CSAE) during and within 7 days post-ablation using STSF catheter, Persistent AF: Primary effectiveness endpoint is the incidence (rate and proportion) of a composite endpoint at 6 months and 1 year after specified index dates Ischemic VT: Primary effectiveness endpoint is the incidence (rate and proportion) of a composite endpoint at 6 months and 1 year after specified index dates
• Data analysis plan:
  Prior to the outcome analysis, the 2-stage propensity score strategy is used within each patient population separately within each health system to reduce confounding in the comparison of outcomes between groups. Demographic, clinical, procedural, and hospital and provider characteristics at baseline will be summarized descriptively for each group. Standard descriptive summaries for continuous variables will include the number of subjects with data, mean, and standard deviation. The count and percentage will be generated for categorical variables. A head-to-head comparison using a non-inferiority design with a pre-specified non-inferiority margin will be conducted for a composite safety endpoint for persistent AF and a single arm design using a performance goal will be conducted for a composite safety endpoint for ischemic VT.