Cryoballoon and Associated Esophageal Effects

Atrial Fibrillation Clinical Trial

Official title:

Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960346
• Other study ID #: 015-238
• Status: Completed
• Phase: N/A
• Start date: November 25, 2015
• Est. completion date: May 2, 2018

Study information

• Verified date: May 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation

2. Age >18 years

3. Planned AF cryoablation procedure

Exclusion Criteria:

1. LA diameter >55mm

2. Severe LVH (LV wall = 15mm)

3. LA thrombus

4. Decompensated heart failure

5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins

6. History of previous pulmonary vein isolation

7. Inability to place esophageal temperature probe or TEE probe

8. Previously documented phrenic nerve injury

9. Known esophageal pathology (complete GI history worksheet)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation with cryoenergy
Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Phrenic nerve injury	To collect data phrenic nerve injury assessed with patient symptom questionnaire	Up to 3 years
Secondary	Post procedure symptoms	To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire	Up to 3 years