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Procedure

Esophageal Cooling During Ablation for Atrial Fibrillation (eCool-US Trial)

N/A

Recruiting

Led By David Callans, MD

Research Sponsored by Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Those in extremities of age (<18 or >85) will not be recruited

Inability to consent for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a cooling probe can protect the oesophagus during ablation, reducing the risk of severe oesophageal damage in AF patients.

Who is the study for?

This trial is for AF patients suitable for ablation treatment under general anesthesia, as per guidelines. They must have already decided on this procedure and be waiting for it. It's not open to those who can't consent, can't follow up with endoscopy, are younger than 18 or older than 85, or have a history of upper GI tract bleeding or esophageal conditions that contraindicate instrumentation during ablation.

What is being tested?

The study compares the safety of two probes during AF ablation: a new cooling probe designed to protect the oesophagus from heat damage versus the standard temperature monitoring probe. Participants will be randomly assigned in equal chance to receive either the new cooling probe or standard care.

What are the potential side effects?

Potential side effects may include discomfort from the esophageal probe insertion and risks associated with thermal energy affecting nearby structures like the oesophagus during heart ablation procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am between 18 and 85 years old.

Select...

I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 4 times, at times: 0, 3, 6, 12 months from time of ablation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from the treated atrial arrhythmia

Secondary study objectives

Ability to attain procedural endpoints during AF ablation.

Fluoroscopy duration (minutes)

Incidence and severity of endoscopically detected esophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours).

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Study groupActive Control1 Intervention

Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees Celsius during ablation of the left atrial posterior wall.

Group II: Control groupActive Control1 Intervention

Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anesthetic. The esophageal temperature probe is placed close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).

0 / 2Eligibility criteria met