N/A
N=303
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
Paroxysmal Atrial Fibrillation · Persistent Atrial Fibrillation · Cardiac Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT03882021 ↗Enrolled (actual)
303
Serious AEs
2.7%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Subjects With One-year Success — 57.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A specific electrophysiology mapping protocol is applicable with the GRID catheter. (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With One-year Success |
57.2 | — |
Summary
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
Eligibility Criteria
Inclusion Criteria
- Documented atrial fibrillation with planned endocardial ablation procedure
- Age 18 years or older
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
- Able and willing to complete all required study procedures through 12 months
Exclusion Criteria
- Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
- Previous ablation or surgery in the left atria
- Implanted left atrial appendage occluder
- Implanted mitral or tricuspid valve replacement
- Implanted cardiac defibrillator (ICD)
- Participation in another clinical investigation that may confound the results of this study
- Pregnant or nursing
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy less than 12 months
Data sourced from ClinicalTrials.gov (NCT03882021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.