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WithdrawnNCT04109053Updated Oct 1, 2025

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

An observational study in Paroxysmal Atrial Fibrillation, sponsored by BayCare Health System. Withdrawn. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by BayCare Health System · Observational

Why this study was withdrawn
PI did not move forward with study
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

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Lead sponsor

BayCare Health System is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. AT/AF free survival

    Time frame: 12 months

  2. Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time.

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04109053
Lead sponsor
BayCare Health System
Responsible party
Sponsor
First posted
Sep 30, 2019
Start date
Mar 2, 2020 (estimated)
Primary completion
Mar 31, 2021 (estimated)
Completion
Apr 30, 2021 (estimated)
Last update
Oct 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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