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NCT04109053 Clinical Trial

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

Paroxysmal Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04109053
Other study ID # Ultrasensitive EAM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date April 30, 2021

Study information
Verified date September 2019
Source BayCare Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date April 30, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BayCare Health System

Outcome
Type Measure Description Time frame Safety issue
Primary 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 AT/AF free survival 12 months
Secondary Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time. 12 months
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