Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to gather data regarding the utilization of the FARAVIEW™ feature of the RHYTHMIA HDx Mapping System when used in conjunction with the FARAWAVE NAV Pulsed Field Ablation catheter in subjects undergoing catheter-based endocardial mapping and catheter-based ablation treatment of Atrial Fibrillation.
The objective of this study is to obtain First-in-Human (FIH) experience with the FARAVIEW™ technology of the RHYTHMIA HDx™ Mapping System when it is used to visualize and track the FARAWAVE NAV™ Pulsed Field Ablation (PFA) catheter in the treatment of Atrial Fibrillation (AF). The study will collect FIH data on user experience and workflow using the FARAVIEW technology to visualize and track the FARAWAVE NAV PFA catheter (part of the FARAPULSE™ Pulsed Field Ablation System). Subjects with Paroxysmal and Persistent Atrial Fibrillation will be included in this study.
NAVIGATE PF Phase 2 has the same objective of the NAVIGATE PF study and incorporates a Day 60 remapping procedure and Day 90 safety follow-up. This procedure has the additional objective to assess durability of isolation and to compare electro-anatomical maps information between Index procedure and Day 60 remapping. One clinical site in Europe that participated in NAVIGATE PF and enrolled under protocol ver A., will contribute enrollments in Phase 2 of the NAVIGATE PF study. Approximately 30 subjects will be enrolled in Phase 2 of the NAVIGATE PF study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation for Paroxysmal or Persistent Atrial Fibrillation | Other | Subjects scheduled to undergo endocardial mapping and Pulmonary Vein Isolation (PVI) in the treatment of atrial fibrillation. For patients with persistent AF, left atrial posterior wall isolation (PWI) may also be performed in addition to PVI at the discretion of the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation Treatment | Device | For subjects with paroxysmal AF, Pulmonary Vein Isolation will be performed with the FARAWAVE NAV catheter. For subjects with persistent AF, left atrial posterior wall isolation (PWI) may also be performed at the discretion of the investigator, with the FARAWAVE NAV PFA catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with PVI success | PVI success is defined as the proportion of veins isolated vs reconnected at the end of the procedure as assessed by a site's standard of care method for testing vein isolation | At the end of the ablation procedure |
| Number of subjects with PWI success | PWI success is defined as the isolation of the left atrial PW at the end of the procedure as assessed by a site's standard of care method for testing | At the end of the ablation procedure |
| Physician feedback on FARAVIEW technology of the RHYTHMIA mapping system by means of a questionnaire | Physician feedback on the FARAVIEW technology of the RHYTHMIA mapping system will be collected by means of a questionnaire. | At the end of the ablation procedure |
| umber of subjects presenting with PV or PW reconnections site's standard of care method. Procedural complications: device and/or procedure-related AEs. | Device and/or procedure-related AEs will be collected to evaluate the procedural complications rate. | At the end of the ablation procedure |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects presenting with PV or PW reconnections (NAVIGATE PF Phase 2 only) | Number of subjects presenting with PV or PW reconnections at the Day-60 remapping procedure, as assessed by a site's standard of care method. | Day-60 remapping procedure |
| Comparison of electro-anatomical maps (NAVIGATE PF Phase 2 only) |
Inclusion Criteria:
Age: ≥ 18 years of age, or older if required by local law
Symptomatic, documented, drug-resistant, Atrial Fibrillation
Informed consent: willing and capable of providing informed consent
Full participation: willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Exclusion Criteria:
Atrial exclusions - Any of the following atrial conditions:
Cardiovascular exclusions - Any of the following CV conditions:
i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated with abnormal LV function or hemodynamic measurements e. Cardiomyopathy i. Hypertrophic cardiomyopathy ii. Cardiac amyloidosis f. Valve prostheses: any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Access issues: any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic disease: rheumatic heart disease i. Anticipated cardiac surgery: awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Any of the following conditions at baseline (Section 10.4):
Any of the following events within 90 Days of the Consent Date:
Bleeding diathesis: thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
Contraindication to anticoagulation: contraindication to, or unwillingness to use, systemic anticoagulation
Pregnancy: women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period
Health conditions that in the investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
Life expectancy: predicted life expectancy less than one (1) year
Participation in another trial: subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
Congenital heart disease: congenital heart disease with any clinically significant residual anatomic or conduction abnormality
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | 15030 | Czechia | |||
| Mater Private Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41919393 | Derived | Reddy VY, Petru J, Funasako M, Canepa S, Metzdorff C, Okeson B, Mikos E, Oesterlein T, Gutbrod SR, Koop BE, Neuzil P. Lesion Durability of the Second Generation Pentaspline Pulsed Field Ablation Catheter NAVIGATE-PF Phase 2 Results. Circ Arrhythm Electrophysiol. 2026 Apr;19(4):e014477. doi: 10.1161/CIRCEP.125.014477. Epub 2026 Apr 1. | |
| 41474406 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Comparison of electro-anatomical maps Index Procedure vs Day 60 |
| Day-60 remapping procedure |
| Dublin |
| 7 D07 RD8P |
| Ireland |
| ClĂnica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Garcia-Bolao I, Reddy VY, Su WW, Koruth JS, Fitzpatrick N, Neuzil P, Rincon RA, Canepa S, Kang K, Oesterlein T, Koop BE, Metzdorff C, Okeson B, Gutbrod SR, Szeplaki G. Visualization of PFA During PVI With the Second-Generation Pentaspline Catheter: NAVIGATE-PF Phase 1 Results. JACC Clin Electrophysiol. 2026 Apr;12(4):802-813. doi: 10.1016/j.jacep.2025.11.016. Epub 2025 Dec 30. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |