Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.

NCT03832959 | Unknown FDA Device

• 1 other identifier: IIBSP-ABL-2018-55
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study evaluates the benefit of using the EnsoETM, a device device for esophageal temperature adjustments, during catheter ablation of atrial fibrillation. Half of participants will undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the other half will undergo catheter ablation with no esophageal temperature adjustment.

Conditions

Atrial Fibrillation; Catheter Ablation; Esophageal Fistula; Esophageal Diseases; Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (3)

• Presence of esophageal damage

  Presence of esophageal lesions will be determined after ablation using esophagogastroscopy.

  1 day

• Severity of esophageal damage

  Degree of esophageal lesions will be determined after ablation using esophagogastroscopy. Degree of esophageal lesions severity will be determined according to the Zargar endoscopy classification (0, I, IIa, IIb, IIIa, IIIb, IV)

  1 day

• Presence of esophageal damage

  Presence of esophageal lesions will be determined after ablation using magnetic resonance imaging

  <48 hours

Secondary Outcomes (1)

• Recurrence of atrial fibrillation

  1 year

Study Arms (2)

Non esophageal protection

NO INTERVENTION

Patients in this group will undergo a first atrial fibrillation catheter ablation procedure with pulmonary vein isolation to study esophageal lesions. The esophageal protection probe will not be used.

Esophageal protection

EXPERIMENTAL

Patients in this group will undergo a first atrial fibrillation catheter ablation procedure with pulmonary vein isolation, using the esophageal protection probe EnsoETM

Device: EnsoETM

Interventions

EnsoETM DEVICE

The EnsoETM is a device with a esophageal probe that can provide temperature adjustment

Esophageal protection

Eligibility Criteria

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

You may qualify if:

• Adult patients (older than 18 years of age) subjected to their first pulmonary vein isolation procedure with a catheter or balloon.

You may not qualify if:

• Patients with known esophageal deformity or evidence of esophageal trauma (for example, history of esophagectomy, previous swallowing disorders, achalasia, etc.)
• Patients with known ingestion of acidic or caustic poison in the previous 24 hours.
• Patients weighing less than 40 kg.
• Patients who know they are pregnant.
• Patients under chronic daily treatment with an proton pump inhibitor or any gastrointestinal acid suppressant.
• Patients under 18 years of age.
• Patients who have not signed the informed consent form.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Atrial Fibrillation; Esophageal Fistula; Esophageal Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Digestive System Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical

Study Officials

• Jose Maria Guerra Ramos, MD PhD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bieito Campos Garcia, MD

CONTACT

+34935565850; bcamposg@santpau.cat

Study Design

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

Model Details: Patients referred for catheter ablation of atrial fibrillation (either cryoablation or radiofrequency ablation (1/1)) will be randomized to either receive or not (1/1) an esophageal temperature adjustment EnsoETM device, to evaluate its role for esophageal protection.

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: February 6, 2019
• Study Start: March 11, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)