vMap Informed Targeting of Arrythmia Location EP
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 112
- Locations
- 10
- Primary Endpoint
- AF Ablation rate of procedural efficacy
Study Overview
Brief Summary
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
Retrospective
Data will be collected from participants who have previously been treated with the approved device as part of routine care.
Intervention: Arrhythmia Mapping (Device)
Prospective
Data will be collected from participants prior to being treated with the approved device as part of routine care.
Intervention: Arrhythmia Mapping (Device)
Outcomes
Primary Outcomes
AF Ablation rate of procedural efficacy
Time Frame: Day of procedure
AF termination or AF non-inducibility in AF ablation cases
Focal Arrhythmia Ablation rate of procedural efficiency
Time Frame: Day of procedure
Total procedure time, fluoroscopy time
Secondary Outcomes
No secondary outcomes reported