Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
NCT ID: NCT07130773
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
58 participants
INTERVENTIONAL
2025-10-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The FARAWAVE Nav PFA catheter, a second-generation device, integrates magnetic navigation capabilities with detailed mapping and PFA therapy into a single tool. This system leverages the FARAVIEW Software Module, offering tailored mapping solutions visualized on the FARAPULSE PFA system, including the creation of voltage and activation maps.
These features address the limitations of the first-generation FARAPULSE catheter and have the potential to improve procedural accuracy and the durability of pulmonary vein isolation. Moreover, they may obviate the need for pre-procedural CT, thereby reducing costs and minimizing patient radiation exposure.
Our study evaluates whether the FARAWAVE Nav catheter, used without pre-ablation CT, allows for a reduction in fluoroscopy time and overall patient radiation exposure compared to the conventional workflow with the FARAPULSE catheter. Furthermore, we will assess procedural time, costs, number of PFA applications, and AF recurrence-free survival
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava
NCT07162597
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
NCT06808217
Contact Force Sensing and Pulmonary Vein Isolation
NCT01630031
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
NCT06099730
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
NCT07021313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The FARAWAVE Nav PFA catheter, a second-generation device, integrates magnetic navigation capabilities with detailed mapping and PFA therapy into a single device. This system leverages the FARAVIEW Software Module, offering tailored mapping solutions visualized on the FARAPULSE PFA System, including the creation of voltage and activation maps. Key technical enhancements of the FARAWAVE Nav PFA catheter include: Field Tag Technology: Field tagging estimates field volume and indicates energy delivery locations. Tags confirm overlap between applications, ensuring comprehensive PV isolation. Voltage/Activation Maps: Mapping data enhances procedure precision, allowing visualization of electrical activation and PV anatomy without reliance on pre-ablation CT imaging. These features address the limitations of the first-generation FARAPULSE catheter and have the potential to enhance procedural accuracy and the durability of pulmonary vein isolation. Moreover, they may eliminate the need for pre-procedural CT or CMR, thereby reducing costs and minimizing patient exposure to radiation.
Our center, like several others, has used the first-generation catheter in routine clinical practice for over a year. More recently, we have also started using the second-generation catheter as part of standard clinical care. Currently, the two devices are used interchangeably, depending on logistical availability, particularly the presence of specialized technicians from Boston Scientific, who are required for the proper operation of the second-generation catheter.
Our study evaluates whether the FARAWAVE Nav catheter, without pre-ablation CT, allows to reduce fluoroscopy time and total patient radiation load as compared to conventional workflow with FARAPULSE catheter. Furthermore, procedural time, costs, number of PFA applications and AF recurrence free survival will be assessed.
Inclusion Criteria
* Atrial fibrillation (AF) documented on a 12-lead ECG, Holter monitor, or implantable cardiac device.
* Candidate for ablation according to current atrial fibrillation guidelines.
* Age ≥18 years at the time of informed consent.
* Signed informed consent obtained.
Exclusion Criteria
* Previous left atrial ablation or left atrial surgery.
* Presence of intracardiac thrombus.
* Persistent atrial fibrillation lasting \>3 years.
* Severe mitral regurgitation or moderate-to-severe mitral stenosis.
* Pregnancy (all women under 50 years undergo an HCG blood test prior to inclusion to exclude pregnancy).
Primary Endpoint
1\. Fluoroscopy Time (measured in minutes)
Secondary Endpoints 2.1 Total Patient Radiation Load 2.2 Procedural Costs 2.3 Procedure Time 2.4 Left Atrial Dwelling Time 2.5 Fluoroscopy Time After Transseptal Puncture 2.6 Number of PFA Applications 2.7 AF Recurrence-Free Survival 2.8 AF Burden (in Patients with implantable loop recorder) 2.9 AF Burden (All Patients)
Randomization: 58 Patients will be randomized 1:1 to:
1. FARAPULSE + pre-ablation CT (Control Group, n=29).
2. FARAWAVE Nav without pre-ablation CT (Intervention Group, n=29). Randomization will be performed using stratified allocation based on Atrial Fibrillation pattern (paroxysmal vs. persistent AF) in a 1:1 fashion.
Intraprocedural fluoroscopy time will be collected at the time of AF ablation procedure.
To determine the required sample size for this study, we performed calculations based on previous studies, the expected fluoroscopy time are:
Control Group: Mean fluoroscopy time = 12 minutes, SD = 8 minutes \[doi.org/10.1161/CIRCULATIONAHA.123.064959\] Intervention Group: Mean fluoroscopy time = 7 minutes, SD = 7 minutes \[doi:10.1161/CIRCEP.122.011780\] Given these assumptions, that correspond to an effect size (Cohen'd) of 0.80, a power of 80% and a 2-sided alpha of 5%, we will need to enrol 52 patients (26 per group). To ensure the study remains adequately powered despite potential dropouts, protocol deviations, or missing data, an additional 10% buffer may be considered, bringing the total recommended enrolment to 58 patients per group. Calculations have been performed using the Stata software (release 18.5, StataCorp, College Station, TX, USA).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
FARAWAVE Nav without pre-ablation CT
Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT
FARAWAVE Nav without pre-ablation CT (Intervention Group, n = 29)
Description of the investigation-specific intervention:
Participants in the intervention group will undergo pulmonary vein isolation (PVI) using the second-generation FARAWAVE Nav pulsed field ablation (PFA) catheter without the use of pre-ablation CT imaging. The FARAWAVE Nav catheter integrates magnetic navigation and electroanatomical mapping capabilities, allowing real-time visualization of left atrial anatomy and electrical signals. Energy delivery is based on non-thermal pulsed electric fields (irreversible electroporation), specifically targeting myocardial tissue while sparing surrounding structures.
Control
FARAPULSE with pre-ablation CT
FARAPULSE with pre-ablation CT
FARAPULSE with pre-ablation CT (Control Group, n = 29)
Description of the investigation-specific intervention:
Participants in the control group will undergo pulmonary vein isolation (PVI) using the first-generation FARAPULSE pulsed field ablation (PFA) catheter. All patients in this group will undergo pre-procedural cardiac CT imaging to evaluate pulmonary vein anatomy and assist in procedural planning. The FARAPULSE catheter delivers non-thermal pulsed electric fields for selective myocardial ablation, aiming to achieve electrical isolation of the pulmonary veins.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT
FARAWAVE Nav without pre-ablation CT (Intervention Group, n = 29)
Description of the investigation-specific intervention:
Participants in the intervention group will undergo pulmonary vein isolation (PVI) using the second-generation FARAWAVE Nav pulsed field ablation (PFA) catheter without the use of pre-ablation CT imaging. The FARAWAVE Nav catheter integrates magnetic navigation and electroanatomical mapping capabilities, allowing real-time visualization of left atrial anatomy and electrical signals. Energy delivery is based on non-thermal pulsed electric fields (irreversible electroporation), specifically targeting myocardial tissue while sparing surrounding structures.
FARAPULSE with pre-ablation CT
FARAPULSE with pre-ablation CT (Control Group, n = 29)
Description of the investigation-specific intervention:
Participants in the control group will undergo pulmonary vein isolation (PVI) using the first-generation FARAPULSE pulsed field ablation (PFA) catheter. All patients in this group will undergo pre-procedural cardiac CT imaging to evaluate pulmonary vein anatomy and assist in procedural planning. The FARAPULSE catheter delivers non-thermal pulsed electric fields for selective myocardial ablation, aiming to achieve electrical isolation of the pulmonary veins.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Candidate for ablation according to current atrial fibrillation guidelines.
* Age ≥18 years at the time of informed consent.
* Signed informed consent obtained
Exclusion Criteria
* Presence of intracardiac thrombus.
* Persistent atrial fibrillation lasting \>3 years.
* Severe mitral regurgitation or moderate-to-severe mitral stenosis.
* Pregnancy (all women under 50 years undergo an HCG blood test prior to inclusion to exclude pregnancy).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardiocentro Ticino
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marco Bergonti
MD PhD
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BASEC-ID 2025-01638
Identifier Type: OTHER
Identifier Source: secondary_id
CCT2025-FaraRadiation
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.