Atrial Fibrillation Paroxysmal Clinical Trial
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
NCT number | NCT06392932 |
Other study ID # | STUDY00002707 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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." |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Smidt Heart Institute | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | Biosense Webster, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of RF ablation lesions to performed pulmonary vein isolation. | During ablation procedure. | ||
Other | RF time during pulmonary vein isolation. | During ablation procedure. | ||
Other | Left atrial dwell time to achieve pulmonary vein isolation. | During ablation procedure. | ||
Other | Achievement of first pass pulmonary vein isolation. | During ablation procedure. | ||
Primary | Maximal change in esophageal temperature during posterior wall isolation. | During ablation procedure. | ||
Secondary | Presence of esophageal thermal injury seen on post-procedure capsule endoscopy. | 2-4 days after ablation procedure. | ||
Secondary | Presence of procedural complications. | During and immediately following ablation procedure. |
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