Clinical trial NCT06392932: Esophageal Temperature During PVI Using Q-DOT Micro
Official title: Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Keywords: Atrial Fibrillation
Esophageal thermal injury
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2024-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective open-label randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.

Eligibility criteria: 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."

Primary outcomes:
measure: Maximal change in esophageal temperature during posterior wall isolation.
timeFrame: During ablation procedure.
Secondary outcomes:
measure: Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.
timeFrame: 2-4 days after ablation procedure.
measure: Presence of procedural complications.
timeFrame: During and immediately following ablation procedure.
Other outcomes:
measure: Number of RF ablation lesions to performed pulmonary vein isolation.
timeFrame: During ablation procedure.
measure: RF time during pulmonary vein isolation.
timeFrame: During ablation procedure.
measure: Left atrial dwell time to achieve pulmonary vein isolation.
timeFrame: During ablation procedure.
measure: Achievement of first pass pulmonary vein isolation.
timeFrame: During ablation procedure.
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Smidt Heart Institute
state: California
Study officials:
References: