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Cryoballoon and Associated Esophageal Effects

NCT03960346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-05-23

No results posted yet for this study

Summary

The primary objectives are to determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively. To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include:

* Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations
* Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations
* Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations As well as to associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.

Conditions

Interventions

PROCEDURE

Ablation with cryoenergy

Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-25
Primary Completion
2018-05-02
Completion
2018-05-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960346 on ClinicalTrials.gov