AI Powered Mapping Technology for Identifying Arrhythmias (VITAL-EP)

Heart Rhythm Clinical and Research Solutions (HRCRS)

Status: Enrolling

Conditions: Arrhythmias, Cardiac

Treatments: Device: Arrhythmia Mapping

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06939478

VITAL-EP

Details and patient eligibility

About

Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Retrospective Arm:

Inclusion Criteria:

1. Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
2. The patient can provide written informed consent, if applicable.
3. The patient is greater than or equal to 18 years old

Prospective Arm:

Inclusion Criteria:

1. Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
2. The patient can provide written informed consent, if applicable.
3. 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:

1. Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
2. Patients in whom no ablation was performed using the vMap equipment.
3. Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
4. In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.

Trial design

110 participants in 2 patient groups

Retrospective

Description:

Data will be collected from participants who have previously been treated with the approved device as part of routine care.

Treatment:

Device: Arrhythmia Mapping

Prospective

Description:

Data will be collected from participants prior to being treated with the approved device as part of routine care.

Treatment:

Device: Arrhythmia Mapping