Impact of Pulmonary Vein Isolation (PVI) Line Modification Based on the Multidetector Computed Tomography (MDCT)-Derived Fingerprinted Esophageal Distance to the Posterior Wall of the Left Atrium, on the Esophageal Temperature Raise Measured With an Intraluminal Esophageal Temperature Monitoring Lead. A Randomized Controlled Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.
Study Overview
Brief Summary
A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice. We have developed an isodistance map (esophageal print) to depict the atrio-esophageal relationship and to analyze the esophageal position peri procedurally. The present randomized study intends to analyze the usefulness of the esophageal print in predicting local thermal heating of the esophagus.
Detailed Description
Primary objective: to validate the usefulness of the esophageal print in avoiding temperature rises caused by radiofrequency (RF) application at the left atrial (LA) posterior wall during atrial fibrillation ablation
Secondary objectives:
- to establish if there is a linear relationship between intraesophageal temperature rise and atrio-esophageal distance as calculated by the MDCT-derived esophageal print.
- to analyze the need for ablation line modification.
- to analyze the need for energy (power settings, ablation index, ablation time, etc.) modification.
- to develop a new multimodal approach to esophageal monitoring during AF/AT ablation.
Interventions
- Pre-procedural scan and Esophageal Isodistance Print
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years.
- •Indication for any atrial fibrillation or left atrial flutter ablation procedure.
- •Documented episodes of atrial arrhythmia (AF/AT/AFL)
- •Signed informed consent.
Exclusion Criteria
- •Age < 18 years.
- •Pregnancy.
- •Impossibility to perform CT Scan.
- •Impossibility to perform transesophageal echocardiography or to insert esophageal temperature monitoring probe.
- •Concomitant investigation treatments.
- •Medical, geographical and social factors that make study participation impractical
- •Inability to give written informed consent.
- •Patient's refusal to participate in the study.
Arms & Interventions
Intervention group or "PRINT" group
The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print, which is the zone where the atrioesophageal distance is shorter. The maximal distance and the area between the original line and the modified line will be noted. In cases when ablation through the red layer is unavoidable, the delivered energy can be lowered to an ablation index (AI) of 300 regardless of the local wall thickness. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.
Intervention: Modification of the pulmonary vein ablation line (Procedure)
Control group
The ablation line will not be modified from the original one drawn before randomization and RF applications will follow the regular path. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.
Intervention: Regular PVI ablation (Procedure)
Outcomes
Primary Outcomes
Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.
Time Frame: 1 day
Number of intraesophageal temperature rises above 39°C or absolute temperature raises of 2°C degrees. The chosen probe is St Jude
Secondary Outcomes
- Proportion of patients needing ablation power or ablation time modification owing to esophageal presence in the immediate posterior wall .(1 day)
Investigators
Antonio Berruezo, MD, PhD
Head of the Arrhytmia Unit
Centro Medico Teknon