Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

NCT02998866 | Completed

• 1 other identifier: PI1002BD
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Cryoballoon Pulmonary Vein Isolation; Esophageal Effects

Outcome Measures

Primary Outcomes (4)

• Temperature Decline

  I. 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 procedure.

  90 days or when complications resolve

• Measurements of esophagus to each pulmonary vein

  II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.

  90 days or when complications resolve

• Create Recommendations for esophageal temperature-guided ablation

  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

  90 days or when complications resolve

• Assessment of additional Adverse Events

  To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.

  90 days or when complications resolve

Secondary Outcomes (1)

• Data collection on Phrenic Injury

  90 days or when complications resolve

Study Arms (1)

Multi-center, prospective outcomes registry

OTHER

The study is a multi-center, prospective outcomes registry

Procedure: Esophageal Temperature-Guided Ablation

Interventions

Esophageal Temperature-Guided Ablation PROCEDURE

Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI \[means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.

Multi-center, prospective outcomes registry

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

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Deville, MD

  The Heart Hospital Baylor of Plano

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: December 21, 2016
• Study Start: November 1, 2015
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: February 21, 2021

Record last verified: 2016-12