Overview
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.
Description
The registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts:
Retrospective Cohort: approximately 60 patients across two sites. Prospective Cohort: approximately 50 patients across two sites. This registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures.
Eligibility
Retrospective Arm:
Inclusion Criteria:
- Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- The patient can provide written informed consent, if applicable.
- The patient is greater than or equal to 18 years old
Prospective Arm:
Inclusion Criteria:
- Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- The patient can provide written informed consent, if applicable.
- The patient is greater than or equal to 18 years old
Exclusion Criteria:
Participants who meet any one of the following criteria will be a screen failure and excluded from participation:
- Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
- Patients in whom no ablation was performed using the vMap equipment.
- Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
- In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.