Esophageal Temperature During PVI Using Q-DOT Micro
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QDOT Micro ablation catheter, ST SF ablation catheter.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation Paroxysmal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device QDOT Micro ablation catheter
QDOT Micro ablation catheter - Device ST SF ablation catheter
ST SF ablation catheter
Primary outcome measures
- Maximal change in esophageal temperature during posterior wall isolation. [Time frame: During ablation procedure.]
Secondary outcome measures (2)
- Presence of esophageal thermal injury seen on post-procedure capsule endoscopy. [Time frame: 2-4 days after ablation procedure.]
- Presence of procedural complications. [Time frame: During and immediately following ablation procedure.]
Eligibility criteria
Inclusion criteria
- 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
- 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
- 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."
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars-Sinai Smidt Heart Institute — Los Angeles
Identifiers
NCT: NCT06392932 · STUDY00002707