Trial · NCT07877519
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Recurrence of Atrial Tachyarrhythmia After the Blanking Period | From the end of the 8-week post-ablation blanking period through 12 months after the index ablation procedure | Recurrence is defined as at least one episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer and documented by electrocardiographic monitoring after the 8-week post-ablation blanking period. Rhythm monitoring will be performed using a wearable electrocardiographic device for at least 7 days at each scheduled follow-up. The outcome will be reported as the percentage of participants with recurrence. |
| Secondary | Percentage of Participants With Successful Procedural Support by the Assigned Anesthesia Strategy | During the index ablation procedure | Successful procedural support is defined as completion of the planned ablation strategy without an anesthesia-related event causing interruption, premature termination, or inability to complete the intended ablation strategy. For participants assigned to local anesthesia with conscious sedation, success requires: (1) no interruption of ablation on three or more occasions because of severe coughing, pain, or agitation; (2) no single interruption lasting more than 5 minutes because of severe coughing, pain, or agitation; and (3) no conversion to general anesthesia because of intolerance of the assigned anesthesia strategy. For participants assigned to general anesthesia, success requires no premature termination of the procedure because of hemodynamic instability, a severe allergic reaction, or another anesthesia-related event. |
| Secondary | Percentage of Participants With Airway Mechanical Injury | From initiation of anesthesia or sedation through discharge from the index hospitalization, an expected average of 2 days. | The percentage of participants experiencing at least one airway mechanical injury, including sore throat, mucosal bleeding, or hoarseness, following the assigned anesthesia or sedation strategy. Individual components will also be recorded separately. |
| Secondary | Percentage of Participants Requiring Conversion From Conscious Sedation to General Anesthesia | During the index ablation procedure | The percentage of participants assigned to local anesthesia with conscious sedation who require conversion to general anesthesia because of persistent severe coughing, pain, anxiety, or agitation interfering with catheter positioning or energy delivery; persistent respiratory depression or refractory hypoxemia; uncorrectable hemodynamic instability; or inability or unwillingness to tolerate the assigned anesthesia strategy. |
| Secondary | Percentage of Participants With Intraoperative Agitation | During the index ablation procedure | The percentage of participants with intraoperative agitation documented by the procedural team during the index ablation procedure. |
| Secondary | Duration of Procedural Area Occupancy | During the index procedure | The elapsed time in minutes from the participant's entry into the procedural area, recorded by the first entry scan, to the participant's exit from the procedural area, recorded by the corresponding exit scan. |
| Secondary | Duration of Catheter Laboratory Occupancy | During the index procedure | The elapsed time in minutes from the participant's entry into the catheter laboratory, recorded by the second entry scan, to the participant's exit from the catheter laboratory, recorded by the corresponding exit scan. |
| Secondary | Percentage of Participants With Acute Pulmonary Vein Isolation Success | At the end of the index ablation procedure | The percentage of participants in whom bidirectional electrical isolation of all targeted pulmonary veins is confirmed at the end of the index ablation procedure. |
| Secondary | Pain Visual Analog Scale Score | Immediately after the index ablation procedure | Pain will be assessed using a 0-to-100 visual analog scale, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater pain. |
| Secondary | Anxiety Visual Analog Scale Score | Immediately after the index ablation procedure | Anxiety will be assessed using a 0-to-100 visual analog scale, where 0 indicates no anxiety and 100 indicates the worst imaginable anxiety. Higher scores indicate greater anxiety. |
| Secondary | Overall Procedural Experience Visual Analog Scale Score | Immediately after the index ablation procedure | Overall procedural experience will be assessed using a 0-to-100 visual analog scale, where 0 indicates the worst possible procedural experience and 100 indicates the best possible procedural experience. Higher scores indicate a better procedural experience. |
| Secondary | Direct Anesthesia- or Sedation-Related Supplies and Medication Cost | During the index procedure and associated procedural preparation and recovery | The total itemized cost in Chinese yuan of supplies and medications directly related to the assigned anesthesia or sedation strategy. Items may include laryngeal masks, anesthesia breathing circuits, anesthesia masks, respiratory filters, intravenous anesthetics, muscle relaxants, reversal agents, local anesthetics, nasal oxygen-delivery supplies, fentanyl, midazolam, dexmedetomidine, and lidocaine, as applicable. |
| Secondary | Anesthesia- or Sedation-Related Monitoring and Service Cost | During the index procedure and associated procedural preparation and recovery | The total cost in Chinese yuan of anesthesia- or sedation-related monitoring and professional services, including respiratory function monitoring under general anesthesia and local anesthesia or sedation procedure fees, as applicable. |
| Secondary | Ancillary and Rescue Care Cost | During the index hospitalization, through discharge (expected an average of 2 days after initiation of anesthesia or sedation). | The total cost in Chinese yuan of ancillary and rescue care associated with the assigned anesthesia or sedation strategy, including oxygen therapy, intravenous access, pressure-monitoring catheters, oxygen sensors, supportive treatment, emergency treatment, and antiemetic medications. |
| Secondary | Percentage of Participants With Anesthesia-Related Adverse Events | From initiation of anesthesia or sedation through 30 days after the index ablation procedure | The percentage of participants experiencing at least one prespecified anesthesia-related adverse event, including sore throat, mucosal bleeding, hoarseness, bradycardia, intraoperative hypotension, hypoxemia, postoperative cognitive dysfunction, or severe vomiting. Each component event will also be recorded and reported separately. |
| Secondary | Percentage of Participants With Ablation-Related Complications | From the index ablation procedure through 12 months after the procedure | The percentage of participants experiencing at least one prespecified ablation-related complication, including cardiac tamponade, pericardial effusion, coronary artery spasm, phrenic nerve injury, kidney injury, hemolysis, or vascular access complications. Each component event will also be recorded and reported separately. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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