Esophageal Temperature During PVI Using Q-DOT Micro
ConditionAtrial Fibrillation Paroxysmal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged greater than or equal to 18 years
Diagnosed with paroxysmal atrial fibrillation
Disqualifiers
Patients who have undergone prior left atrial ablation procedures.
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.
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)
Any records flagged "break the glass" or "research opt out."
Trial design
Design model
Parallel
Treatments tested in this trial
QDOT Micro ablation catheter
DeviceQDOT Micro ablation catheter
ST SF ablation catheter
DeviceST SF ablation catheter
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: QDOT ArmExperimental treatment 1 intervention
Group B: ST SF ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximal change in esophageal temperature during posterior wall isolation.
Time frame
During ablation procedure.Secondary outcomes
1
Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.
Time frame
2-4 days after ablation procedure.2
Presence of procedural complications.
Time frame
During and immediately following ablation procedure.Other outcomes
1
Number of RF ablation lesions to performed pulmonary vein isolation.
Time frame
During ablation procedure.2
RF time during pulmonary vein isolation.
Time frame
During ablation procedure.3
Left atrial dwell time to achieve pulmonary vein isolation.
Time frame
During ablation procedure.4
Achievement of first pass pulmonary vein isolation.
Time frame
During ablation procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
Biosense Webster, Inc.
Collaborator
Source ClinicalTrials.gov