Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation
NCT07927582, Not applicable, Not yet recruiting, China National Center for Cardiovascular Diseases
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation | ClinicalTrials.gov |
| NCT number | NCT07927582 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | China National Center for Cardiovascular Diseases | ClinicalTrials.gov |
| Conditions | Atrial Fibrillation (AF) | ClinicalTrials.gov |
| Interventions | Deep sedation, General Aneasthesia | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of the composite failure events, including clinical hypoxemia, clinical hypotension, and anesthesia failure. | During the index procedure | 1. Anesthesia failure is defined as intolerance to the randomly assigned anesthetic regimen during the procedure, requiring a switch to an alternative anesthetic approach to ensure procedural success. 2. Clinical hypoxemia is defined as oxygen saturation \< 85% lasting for 1 minute or the need for clinical intervention (increased fraction of inspired oxygen, airway management, or drug administration) or resulting in procedure discontinuation. 3. Clinical hypotension is defined as systolic blood pressure \< 85 mmHg lasting for at least 1 minute or the need for pharmacological intervention or resulting in procedure discontinuation | ClinicalTrials.gov |
| Secondary | The incidences of anesthesia-related adverse events (e.g., vomiting, dry cough, cognitive dysfunction, airway injury). | During the index procedure | ClinicalTrials.gov | |
| Secondary | Early recurrence rate at 2 months | 60 days | Defined as the proportion of subjects with documented atrial arrhythmias lasting ≥30s within 60 days | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)