FARAFLEX Mapping and PFA System for Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
Recruiting
N/AInterventional Study
Atrial FibrillationPersistent Atrial FibrillationParoxysmal AF
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Boston Scientific Corporation · Industry
Who this trial is looking for
This trial is looking for adults with persistent or paroxysmal atrial fibrillation who are experiencing symptoms. Participants will evaluate the safety and effectiveness of a new catheter treatment.
Are You a Good Fit for This Trial?
Rules you outKnown severe coronary diseaseActive malignancyHeart failure
You may be able to join if
I am 18 years old or older.
I have symptoms of persistent or paroxysmal atrial fibrillation.
I can provide informed consent.
I can attend all follow-up assessments.
You may not be able to join if
I have a left atrial size that is too large.
I have had previous heart surgery or procedures for atrial problems.
I have an untreated atrial thrombus.
I have a history of serious heart conditions like heart failure.
I have had a heart attack or cardiac surgery in the last 90 days.
I have severe lung or kidney problems.
I am currently pregnant or plan to become pregnant soon.
I have an active cancer diagnosis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Status
Eligibility Criteria
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 clini…
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
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