HD Mapping of Atrial Fibrillation in Asia Pacific

Abbott

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: Catheter ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT04022954

CRD975

Details and patient eligibility

About

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule

2. Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)

3. Subject is diagnosed with AF as defined by:

   • Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
   • Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months

4. Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF

5. Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

Exclusion criteria

1. Previous ablation or surgery in the left atria
2. Implanted left atrial appendage occluder
3. Implanted mitral or tricuspid valve replacement
4. Implanted cardiac defibrillator (ICD)
5. Participation in another clinical investigation that may confound the results of this study
6. Pregnant or nursing
7. 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.
8. Life expectancy less than 12 months

Trial design

200 participants in 2 patient groups

Inquiry™ AFocusII™ Double Loop

Description:

The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart.

Treatment:

Device: Catheter ablation

Advisor™ HD Grid, Sensor Enabled™

Description:

The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Treatment:

Device: Catheter ablation