The Evaluation of User Experience With FARAVIEW™ Technology of the OPAL HDx™ Mapping System When Used With the FARAWAVE NAV™ ULTRA Pulsed Field Ablation Catheter in the Treatment of Atrial Fibrillation
NCT07925359, Not applicable, Not yet recruiting, Boston Scientific Corporation
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Evaluation of User Experience With FARAVIEW™ Technology of the OPAL HDx™ Mapping System When Used With the FARAWAVE NAV™ ULTRA Pulsed Field Ablation Catheter in the Treatment of Atrial Fibrillation | ClinicalTrials.gov |
| NCT number | NCT07925359 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Boston Scientific Corporation | ClinicalTrials.gov |
| Conditions | Atrial Fibrillation (AF), Paroxysmal AF, Persistent Atrial Fibrillation (PersAF), FARAPULSE | ClinicalTrials.gov |
| Interventions | Ablation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping System | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of device-related or procedure-related events of a serious nature | Day 0 (ablation procedure) - Day 7; Day 0 - Day 30; Day 0 - Day 60 | Safety will be assessed for subjects who undergo ablation using the investigational system configuration of the FARAPULSE™ PFA System during the Index Procedure or any repeat PFA procedure using the investigational system configuration. Safety will be characterized descriptively by the incidence of device-related or procedure-related events of a serious nature with onset dates within the follow-up intervals: Day 0-7; Day 0-30; Day 0-60. | ClinicalTrials.gov |
| Primary | Acute Procedural Success for PV and LAPW Isolation | At the end of the ablation procedure | * The proportion of de novo subjects that achieve acute procedural success (APS) defined as percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and left atrial posterior wall (LAPW) during the index procedure. * The proportion of redo subjects that achieve acute procedural success defined as percutaneous endocardial creation of touch-up lesions required for re-isolation of the PVs and LAPW during the Index Procedure. APS will be clinically assessed by entrance and/or exit block or confirmed by electroanatomical mapping for the PVs and by the site's standard of care method for LAPW. Redo subjects not requiring PV ablation will be excluded from the evaluation of acute PV isolation success. | ClinicalTrials.gov |
| Primary | Acute Procedural Success for CTI, MI and SVC Ablation | At the end of the ablation procedure | * The proportion of subjects undergoing cavotricuspid (CTI) ablation using the FARAWAVE NAV Ultra PFA Catheter in whom bidirectional conduction block across the CTI line is achieved during the Index procedure. * The proportion of subjects undergoing mitral isthmus (MI) ablation using the FARAWAVE NAV Ultra PFA Catheter in whom conduction block across the MI line is achieved during the Index procedure. * The proportion of subjects undergoing superior vena cava (SVC) ablation using the FARAWAVE NAV Ultra PFA Catheter in whom electrical isolation of the SVC is achieved during the Index procedure. Acute procedural success for CTI, MI, and SVC ablation lesions will be assessed according to each study site's standard-of-care method. | ClinicalTrials.gov |
| Primary | Acute Procedural Success - Timing | At the end of the ablation procedure | Acute procedural effectiveness will be evaluated using procedural performance measures, including but not limited ablation time per lesion set, total procedure time, fluoroscopy time, left atrial dwell time, and transseptal access timing, assessed during the 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 |
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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)