Atrial Fibrillation Paroxysmal
Conditions
Keywords
Atrial Fibrillation, Esophageal thermal injury
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.
Interventions
DEVICEQDOT Micro ablation catheter
QDOT Micro ablation catheter
DEVICEST SF ablation catheter
ST SF ablation catheter
Sponsors
Biosense Webster, Inc.
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Interpreters of the esophageal capsule endoscopy will be blinded to study group.
Intervention model description
Prospective open-label randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal change in esophageal temperature during posterior wall isolation. | During ablation procedure. |
Secondary
| Measure | Time frame |
|---|---|
| Presence of esophageal thermal injury seen on post-procedure capsule endoscopy. | 2-4 days after ablation procedure. |
| Presence of procedural complications. | During and immediately following ablation procedure. |
Other
| Measure | Time frame |
|---|---|
| Achievement of first pass pulmonary vein isolation. | During ablation procedure. |
| Left atrial dwell time to achieve pulmonary vein isolation. | During ablation procedure. |
| Number of RF ablation lesions to performed pulmonary vein isolation. | During ablation procedure. |
| RF time during pulmonary vein isolation. | During ablation procedure. |
Countries
United States
Contacts
Primary ContactEric D Braunstein, MD
Backup ContactTansy Aguilar
Outcome results
None listed