High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiac Arrhythmia
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All subjects enrolled will undergo the same mapping and ablation protocol.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) ap...
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification. This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation. Approximately 300 subjects at up to 20 sites worldwide will be enrolled. Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
Tracking Information
- NCT #
- NCT03882021
- Collaborators
- Not Provided
- Investigators
- Study Director: Kristin Ruffner Abbott
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