Arrhythmias, Cardiac
Conditions
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.
Interventions
DEVICEArrhythmia Mapping
vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Sponsors
Heart Rhythm Clinical and Research Solutions, LLC
Vektor Medical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AF Ablation rate of procedural efficacy | Day of procedure | AF termination or AF non-inducibility in AF ablation cases |
| Focal Arrhythmia Ablation rate of procedural efficiency | Day of procedure | Total procedure time, fluoroscopy time |
Countries
United States
Outcome results
None listed