Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT04109053
• Lead Sponsor: BayCare Health System

Brief Summary

Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Detailed Description

Collected data include procedural parameters relevant to pulmonary vein isolation as outlined in the protocol section, DE identified patient demographics, follow up information including rhythm status, antiarrhythmic medication usage, and symptoms or signs to suggest procedural complications relevant to the pulmonary vein isolation procedure.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30
• Study Start: 2019-10-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of acute pulmonary vein isolation as adjudicated by pacing catheter based entrance/exit block, and Orion derived activation and voltage map.	12 months

Secondary Outcome Measures

Name	Time	Method
Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time.	12 months
AT/AF free survival	12 months