Atrial FibrillationELEVATE-PFNCT06510556
Feasibility Study of the FARAFLEX Mapping and PFA System
A study testing FARAFLEX Ablation Treatment and ELEVATE-COR Sub-study in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 4 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- What is being tested?
- FARAFLEX Ablation Treatment and ELEVATE-COR Sub-study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 17 Feb 2025to 15 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age, or older if required by local law
- Symptomatic, documented, Persistent AF or Paroxysmal AF
- Willing and capable of providing informed consent
- Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
- Meets all inclusion criteria according to the ELEVATE-PF Protocol
- Planned for adjunctive CTI ablation
- Willing and capable of participating in all assessments and testing associated with this sub-study protocol.
Who cannot join
- 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
Show all 59Show fewer
- 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
- 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.
- 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
- Known coagulopathy disorder (e.g. von Willibrand's disease, hemophilia)
- Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
- 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
- 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:
- Meets any of the exclusion criteria outlined in the ELEVATE-PF Protocol
- Pre-existing right coronary artery stent and/or left circumflex artery stent
- Known severe non-revascularizable coronary disease
- Moderate to severe coronary artery disease that in the opinion of the investigator would put the patient at increased risk
- Known calcium score ≥1000
- 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
- Contraindication to IVUS
- Body Mass Index (BMI) > 35.0
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel Hospital
Brussels
Eline Kees, eline.kees@uzbrussel.be
Carlo de Asmundis
Croatia1 site, 1 recruiting
- Recruiting
Klinicki bolnicki centar Split
Split
Ante Borovina, MD, anteborovina80@gmail.com
Ante Anic
Czechia1 site, 1 recruiting
- Recruiting
Nemocnice Na Homolce Hospital
Prague
Marko Tichy, MD, marko.tichy@homolka.cz
Petr Neuzil
Italy1 site, 1 recruiting
- Recruiting
Fondazione PTV - Policlinico Tor Vergata
Roma
Chiara Gennaccari, chiara.gennaccari@ptvonline.it
Andrea Natale
About this study
Official title: 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).
Read the 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.
- Being tested
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAFLEX Ablation TreatmentDevice
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.
ELEVATE-COR Sub-studyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FARAFLEX Treatment group | Other | 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. Receives: Device: FARAFLEX Ablation Treatment |
| ELEVATE-COR sub-study group | Other | 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. Receives: Device: ELEVATE-COR Sub-study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: At the end of the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start17 Feb 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 200 FARAFLEX treatment subjects will be enrolled and treated with the investigational FARAFLEX™ Mapping and PFA System. Approximately 50 ELEVATE-COR sub-study subjects will be enrolled and randomized to be treated with either the FARAFLEX™ Mapping and PFA System or a commercially approved ablation system per IFU and medical guidelines. Sub-study subjects will undergo intravascular ultrasound (IVUS) imaging of the right coronary artery (RCA).
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510556
- Sponsor's protocol ID
- PF306
- Other IDs
- ELEVATE-COR
- Acronym
- ELEVATE-PF
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No