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Trial · NCT07877519

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of Participants With Recurrence of Atrial Tachyarrhythmia After the Blanking PeriodFrom 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.
SecondaryPercentage of Participants With Successful Procedural Support by the Assigned Anesthesia StrategyDuring 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.
SecondaryPercentage of Participants With Airway Mechanical InjuryFrom 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.
SecondaryPercentage of Participants Requiring Conversion From Conscious Sedation to General AnesthesiaDuring 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.
SecondaryPercentage of Participants With Intraoperative AgitationDuring the index ablation procedureThe percentage of participants with intraoperative agitation documented by the procedural team during the index ablation procedure.
SecondaryDuration of Procedural Area OccupancyDuring 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.
SecondaryDuration of Catheter Laboratory OccupancyDuring 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.
SecondaryPercentage of Participants With Acute Pulmonary Vein Isolation SuccessAt the end of the index ablation procedureThe percentage of participants in whom bidirectional electrical isolation of all targeted pulmonary veins is confirmed at the end of the index ablation procedure.
SecondaryPain Visual Analog Scale ScoreImmediately after the index ablation procedurePain 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.
SecondaryAnxiety Visual Analog Scale ScoreImmediately after the index ablation procedureAnxiety 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.
SecondaryOverall Procedural Experience Visual Analog Scale ScoreImmediately 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.
SecondaryDirect Anesthesia- or Sedation-Related Supplies and Medication CostDuring 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.
SecondaryAnesthesia- or Sedation-Related Monitoring and Service CostDuring 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.
SecondaryAncillary and Rescue Care CostDuring 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.
SecondaryPercentage of Participants With Anesthesia-Related Adverse EventsFrom 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.
SecondaryPercentage of Participants With Ablation-Related ComplicationsFrom 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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