Trial · NCT07877519
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
NCT07877519, Not applicable, Recruiting, China National Center for Cardiovascular Diseases
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation. Trials, record NCT07877519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
- NCT number
- NCT07877519
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 390 participants, estimated
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
Local Anesthesia With Conscious Sedation, General Anesthesia, VARIPULSE Pulsed Field Ablation System, Compound methoxyphenamine capsules, Salbutamol, Budesonide, Lidocaine, Fentanyl, Midazolam, Tropisetron hydrochloride, Dexamethasone, Atropine
- First posted
- 2026-10-16
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07877519
GET https://conductscience.org/api/trials/v1/NCT07877519/registered