Unipolar Voltage-Guided Substrate Modification Plus Pulsed Field Ablation Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation
NCT07926854, 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 | Unipolar Voltage-Guided Substrate Modification Plus Pulsed Field Ablation Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation | ClinicalTrials.gov |
| NCT number | NCT07926854 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 294 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | China National Center for Cardiovascular Diseases | ClinicalTrials.gov |
| Conditions | Atrial Fibrillation (AF) | ClinicalTrials.gov |
| Interventions | VARIPULSE Pulsed Field Ablation System, Pulmonary Vein Isolation, Individualized Substrate Modification | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Treatment Success at 12 Months After the Index Ablation Procedure | 12 months after the index ablation procedure | Freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter lasting more than 30 seconds after a 90-day blanking period while off class I/III antiarrhythmic drugs, allowing up to one repeat ablation within 6 months of the index procedure (1-2 procedures total). Patients who remain on class I/III antiarrhythmic drugs at 12 months are counted as treatment failures; missing primary outcome data are counted as treatment failures. | ClinicalTrials.gov |
| Secondary | Time to First Recurrence After a Single Procedure Off Antiarrhythmic Drugs | 12 months after the index procedure | ClinicalTrials.gov | |
| Secondary | Change in AFEQT Quality-of-Life Score From Baseline to 12 Months | Baseline and 12 months | ClinicalTrials.gov | |
| Secondary | Incidence of Prespecified Procedure-Related Complications | 90 days after ablation; all-cause mortality at 12 months | ClinicalTrials.gov | |
| Secondary | Freedom From Atrial Arrhythmia at 12 Months After a Single Procedure Off Antiarrhythmic Drugs | 12 months | ClinicalTrials.gov | |
| Secondary | Freedom From Atrial Arrhythmia at 12 Months After a Single Procedure With or Without Antiarrhythmic Drugs | 12 months | ClinicalTrials.gov | |
| Secondary | Freedom From Atrial Arrhythmia at 12 Months After 1-2 Procedures With or Without Antiarrhythmic Drugs | 12 months | ClinicalTrials.gov | |
| Secondary | Freedom From Atrial Fibrillation at 12 Months After 1-2 Procedures Off Antiarrhythmic Drugs | 12 months | ClinicalTrials.gov | |
| Secondary | Atrial Arrhythmia Burden at 3, 6, and 12 Months | 14-day period before each follow-up visit | ClinicalTrials.gov | |
| Secondary | Time to First Recurrence After Any Number of Procedures | 12 months | ClinicalTrials.gov | |
| Secondary | Number of Repeat Ablations Within 12 Months | 12 months after the index procedure | ClinicalTrials.gov | |
| Secondary | Procedure Duration | Index procedure | ClinicalTrials.gov | |
| Secondary | Total Fluoroscopy Time | Index procedure | 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)