Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon
Sponsor
BayCare Health System (Other)
Overall Status
Unknown status
CT.gov ID
NCT04109053
Collaborator
(none)
70
19
Study Details
Study Description
Brief Summary
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Study Type:
Observational
Anticipated Enrollment
:
70 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon
Anticipated Study Start Date
:
Oct 1, 2019
Anticipated Primary Completion Date
:
Mar 31, 2021
Anticipated Study Completion Date
:
Apr 30, 2021
Outcome Measures
Primary Outcome Measures
- 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
- AT/AF free survival [12 months]
- Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time. [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- BayCare Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
BayCare Health System
ClinicalTrials.gov Identifier:
NCT04109053
Other Study ID Numbers:
- Ultrasensitive EAM
First Posted:
Sep 30, 2019
Last Update Posted:
Sep 30, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: