Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998866
• Other study ID #: PI1002BD
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 23, 2018

Study information

• Verified date: December 2016
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: 1
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 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
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Esophageal Temperature-Guided Ablation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Data collection on Phrenic Injury	Assess participants with abnormal imaging and/or adverse events that are related to the treatment.	90 days or when complications resolve