New study checks heat risk to throat during heart procedure
NCT ID NCT06392932
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how two different catheters used to treat atrial fibrillation (a type of irregular heartbeat) affect the temperature of the esophagus (the tube connecting the mouth to the stomach) and the risk of injury to it. About 30 adults with paroxysmal atrial fibrillation will be enrolled. The goal is to understand which approach is safer for the esophagus during the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged greater than or equal to 18 years 4. Diagnosed with paroxysmal atrial fibrillation 5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned Exclusion Criteria: 1. Patients who have undergone prior left atrial ablation procedures. 2. Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe. 3. Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc) 4. Any records flagged "break the glass" or "research opt out."
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Smidt Heart Institute
RECRUITINGLos Angeles, California, 90048, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Pulsed electric fields take aim at irregular heartbeats
- Could a bigger balloon tame the Heart's electrical chaos?
- Can a new heart ablation technique work without x-rays?
- Could a gentle sedation cocktail replace general anesthesia for heart ablation?
- Can a new freezing balloon tame a fluttering heart as well as the old one?
- Heart signals may reveal if a common AFib procedure will last