Feasibility Study of the FARAFLEX Mapping and PFA System (ELEVATE-PF)

Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation

The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Persistent Atrial Fibrillation; Paroxysmal AF
• Intervention / Treatment: Device: FARAFLEX Ablation Treatment; Device: ELEVATE-COR Sub-study

Detailed Description

The objective of this study is to obtain First-in-Human (FIH) experience with the FARAFLEX mapping and PFA catheter in the treatment of persistent Atrial Fibrillation (persAF) or Paroxysmal Atrial Fibrillation (PAF).

Subjects with symptomatic Persistent Atrial Fibrillation or symptomatic Paroxysmal Atrial Fibrillation will be included in this study.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharda Mehta; Phone Number: 800-227-3422; Email: sharda.mehta@bsci.com
• Study Contact Backup: Name: Maria Grazia Pietropaolo; Phone Number: +393463514999; Email: MariaGrazia.Pietropaolo@bsci.com

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • UZ Brussel Hospital
    • Principal Investigator: Carlo de Asmundis
    • Contact: Ileana Smets, MD; Email: Ileana.Smets@uzbrussel.be
• Croatia
  • Split, Croatia
    • Recruiting
    • Klinicki bolnicki centar Split
    • Principal Investigator: Ante Anic
    • Contact: Ante Borovina, MD; Email: anteborovina80@gmail.com
• Czechia
  • Prague, Czechia
    • Recruiting
    • Nemocnice Na Homolce Hospital
    • Principal Investigator: Petr Neuzil
    • Contact: Marko Tichy, MD; Email: marko.tichy@homolka.cz
• Italy
  • Roma, Italy
    • Recruiting
    • Fondazione PTV - Policlinico Tor Vergata
    • Principal Investigator: Andrea Natale
    • Contact: MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years of age, or older if required by local law
2. Symptomatic, documented, Persistent AF or Paroxysmal AF
3. Willing and capable of providing informed consent
4. 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:

1. Atrial exclusions - Any of the following atrial conditions:

   • Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non indexed volume >100 ml (by MRI, CT or TTE report or physician note)
   • Any prior atrial endocardial, epicardial or surgical ablation procedure for atrial arrhythmia other than ablation for right sided SVT
   • Current atrial myxoma
   • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
   • Current left atrial thrombus

2. Cardiovascular exclusions - Any of the following CV conditions:

   • History of sustained ventricular tachycardia or any ventricular fibrillation AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
   • Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion
   • Valvular disease that is symptomatic or is the cause of heart failure.
   • Hypertrophic cardiomyopathy
   • Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
   • Known inability to obtain vascular access or other contraindication to femoral access
   • Rheumatic heart disease
   • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
   • Known allergic drug reaction to nitroglycerin1
   • Known severe non-revascularizable coronary disease
   • Pre-existing right coronary artery stent and left circumflex artery

3. Any of the following conditions at baseline:

   • Heart failure associated with NYHA Class IV
   • LVEF < 40%
   • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment
   • Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.

4. Any of the following events within 90 Days of the Consent Date:

   • Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention
   • Any cardiac surgery
   • Heart failure hospitalization
   • Pericarditis or symptomatic pericardial effusion
   • Gastrointestinal bleeding
   • Stroke, TIA, or intracranial bleeding
   • Any non-neurologic thromboembolic event
   • Carotid stenting or endarterectomy
5. Known coagulopathy disorder (e.g. von Willibrand's disease, hemophilia)
6. Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
7. 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

8. Any of the following health conditions that 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:

   • Body Mass Index (BMI) > 42.0
   • Solid organ or hematologic transplant, or currently being evaluated for a transplant
   • Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
   • Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
   • Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant
   • Active malignancy at enrollment (other than squamous cell carcinoma)
   • Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
   • Active systemic infection
   • Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (>30 pauses per hour)
   • Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure

10. Predicted life expectancy less than one (1) year 11. 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 12. Any of the following congenital conditions:

• Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
• History of known congenital methemoglobinemia
• History of known G6PD deficiency

ELEVATE-COR (additional) Eligibility Criteria:

Inclusion Criteria:

1. Meets all inclusion criteria according to the ELEVATE-PF Protocol
2. Planned for adjunctive CTI ablation
3. Willing and capable of participating in all assessments and testing associated with this sub-study protocol.

Exclusion Criteria:

1. Meets any of the exclusion criteria outlined in the ELEVATE-PF Protocol
2. Pre-existing right coronary artery stent and/or left circumflex artery stent
3. Known severe non-revascularizable coronary disease
4. Moderate to severe coronary artery disease that in the opinion of the investigator would put the patient at increased risk
5. Known calcium score ≥1000
6. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant
7. Contraindication to IVUS
8. Body Mass Index (BMI) > 35.0

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FARAFLEX Treatment group; 200 subjects scheduled to undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with FARAFLEX mapping PFA catheter and other BSC devices.	Device: FARAFLEX Ablation Treatment; Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using the investigational Boston Scientific FARAFLEX Mapping and Pulse Field Ablation (PFA) System, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator.
Other: ELEVATE-COR sub-study group; Approximately 50 subjects meeting study eligibility requirements will be enrolled in the sub-study at a subset of centers and randomized to undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with either the FARAFLEX™ Mapping and PFA System or a commercially approved ablation system. Subjects will also undergo IVUS imaging of their RCA at the following time points: pre- and post-ablation, 3-Months, 12-Months.	Device: ELEVATE-COR Sub-study; Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using either FARAFLEX™ Mapping and PFA System or a commercially available ablation system, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator, per the selected catheter's IFU and in accordance with the guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device or procedure-related Composite Serious Adverse Events (CSAEs)	the incidence of device or procedure-related Composite Serious Adverse Events (CSAEs) following the Index Procedure will be evaluated. Safety analyses will be reported by AF type (Paroxysmal vs. Persistent) and treatment group (FARAFLEX vs. Commercial catheter).	Ablation Procedure (Day 0) - Day 7; Day 0- Day 30; Day 0- Day 360
Acute Procedural Success	The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and the posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block. Effectiveness analyses will be reported by AF type (Paroxysmal vs. Persistent) and treatment group (FARAFLEX vs. Commercial catheter).	At the end of the ablation procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PF306; ELEVATE-COR (Other Identifier: A sub-study of the ELEVATE-PF Study.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No