Cryoballoon and Associated Esophageal Effects

NCT03960346 | Completed DMC

• 1 other identifier: 015-238
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Rate of temperature decline

  Compare the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation using a esotest probe esophageal temperature probe to record the esophageal temperatures

  Up to 3 years

• Associate the development of symptoms

  To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations using a symptom questionnaire and visualize the esophagus 4-7 days post procedure via esophagoscopy

  Up to 3 years

Secondary Outcomes (2)

• Phrenic nerve injury

  Up to 3 years

• Post procedure symptoms

  Up to 3 years

Study Arms (1)

Esophageal Effects

OTHER

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. Esophageal temperature probe is used during cryoablation to measure temperatures and then a 4-7 days post procedure esophagoscopy is performed to evaluate the physical effects on the esophagus.

Procedure: Ablation with cryoenergy

Interventions

Ablation with cryoenergy PROCEDURE

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

Also known as: esophageal temperature-guided ablation

Esophageal Effects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
• Age \>18 years
• Planned AF cryoablation procedure

You may not qualify if:

• LA diameter \>55mm
• Severe LVH (LV wall ≥ 15mm)
• LA thrombus
• Decompensated heart failure
• Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
• History of previous pulmonary vein isolation
• Inability to place esophageal temperature probe or TEE probe
• Previously documented phrenic nerve injury
• Known esophageal pathology (complete GI history worksheet)

Sponsors & Collaborators

• Baylor Research Institute: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: May 23, 2019
• Study Start: November 25, 2015
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: May 23, 2019

Record last verified: 2018-05