Feasibility Study on the FARAVIEW Technology

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

• Registration Number: NCT06175234
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age: = 18 years of age, or older if required by local law<br><br> 2. Symptomatic, documented, drug-resistant, Atrial Fibrillation<br><br> 1. Documented: at a minimum a physician's note confirming the arrhythmia symptoms<br> and durations AND within 180 days of the Enrollment Date one (1) ECG from any<br> regulatory cleared rhythm monitoring device showing AF<br><br> 2. Drug-resistant: effectiveness failure of, intolerance to, or specific<br> contraindication to at least one (1) AAD (Class I, II, III or IV) 1<br><br> 3. Informed consent: willing and capable of providing informed consent<br><br> 4. Full participation: willing and capable of participating in all follow-up<br> assessments and testing associated with this clinical investigation at an approved<br> clinical investigational center<br><br>Exclusion Criteria:<br><br> 1. Atrial exclusions - Any of the following atrial conditions:<br><br> 1. Prior atrial ablation: any prior atrial endocardial, epicardial or surgical<br> ablation procedure for arrhythmia other than ablation for right sided SVT or<br> cavotricuspid isthmus ablation<br><br> 2. Atrial myxoma: current atrial myxoma<br><br> 3. Pulmonary veins: any PV abnormality, stenosis, or stenting (common and middle<br> PVs are admissible)<br><br> 4. Atrial thrombus: current left atrial thrombus<br><br> 5. Long standing persistent AF: continuous AF lasting longer than 12 months<br><br> 2. Cardiovascular exclusions - Any of the following CV conditions:<br><br> 1. Ventricular arrhythmia: history of sustained ventricular tachycardia or any<br> ventricular fibrillation<br><br> 2. Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease,<br> alcohol, or other reversible / non-cardiac causes<br><br> 3. Cardiac devices and implants: current or anticipated pacemaker, implantable<br> cardioverter defibrillator or cardiac resynchronization therapy devices,<br> interatrial baffle, closure device, patch, or patent foramen ovale or ASD<br> occluder, LA appendage closure, device or occlusion.<br><br> 4. Clinically significant valvular disease: valvular disease that is any of the<br> following:<br><br> i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated<br> with abnormal LV function or hemodynamic measurements e. Cardiomyopathy i.<br> Hypertrophic cardiomyopathy ii. Cardiac amyloidosis f. Valve prostheses: any<br> prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g.<br> Access issues: any IVC filter, known inability to obtain vascular access or other<br> contraindication to femoral access h. Rheumatic disease: rheumatic heart disease i.<br> Anticipated cardiac surgery: awaiting cardiac transplantation or other cardiac<br> surgery within the next 12 months<br><br> 3. Any of the following conditions at baseline (Section 10.4):<br><br> 1. Heart failure NYHA Heart failure associated with NYHA IV<br><br> 2. Ejection fraction: LVEF < 40%<br><br> 4. Any of the following events within 90 Days of the Consent Date:<br><br> 1. Coronary disease: myocardial infarction (MI), unstable or coronary intervention<br><br> 2. Cardiac surgery: any cardiac surgery<br><br> 3. Heart failure hospitalization: heart failure hospitalization<br><br> 4. Pericardium: pericarditis or symptomatic pericardial effusion<br><br> 5. GI bleeding: gastrointestinal bleeding<br><br> 6. Neurovascular event: stroke, TIA, or intracranial bleeding<br><br> 7. Thromboembolism: any non-neurologic thromboembolic event<br><br> 8. Carotid intervention: carotid stenting or endarterectomy<br><br> 5. Bleeding diathesis: thrombocytosis, thrombocytopenia, disorder of blood clotting or<br> bleeding diathesis<br><br> 6. Contraindication to anticoagulation: contraindication to, or unwillingness to use,<br> systemic anticoagulation<br><br> 7. Pregnancy: women of childbearing potential who are pregnant, lactating, not using<br> medical birth control or who are planning to become pregnant during the anticipated<br> study period<br><br> 8. Health conditions that in the investigator's medical opinion would prevent<br> participation in the study, interfere with assessment or therapy, significantly<br> raise the risk of study participation, or modify outcome data or its interpretation,<br> including but not limited to:<br><br> 1. Obesity: Body Mass Index (BMI) > 45.0<br><br> 2. Transplantation: solid organ or hematologic transplant, or currently being<br> evaluated for a transplant<br><br> 3. Diaphragmatic abnormality: any prior history or current evidence of<br> hemi-diaphragmatic paralysis or paresis<br><br> 4. Pulmonary: severe lung disease, pulmonary hypertension, or any lung disease<br> involving abnormal blood gases or requiring supplemental oxygen<br><br> 5. Renal: renal insufficiency if an estimated glomerular filtration rate (eGFR) is<br> < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal<br> transplant<br><br> 6. Malignancy: active malignancy (other than cutaneous basal cell or squamous cell<br> carcinoma)<br><br> 7. Gastrointestinal: clinically significant gastrointestinal problems involving<br> the esophagus or stomach including severe or erosive esophagitis, uncontrolled<br> gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal<br> ulceration<br><br> 8. Infections: active systemic infection<br><br> 9. COVID-19 disease: known positive test for COVID-19 and disease not clinically<br> resolved<br><br> 9. Life expectancy: predicted life expectancy less than one (1) year<br><br> 10. Participation in another trial: subjects who are currently enrolled in another<br> investigational study or registry that would directly interfere with the current<br> study, except when the subject is participating in a mandatory governmental<br> registry, or a purely observational registry with no associated treatments; each<br> instance must be brought to the attention of the Sponsor to determine eligibility<br><br> 11. Congenital heart disease: congenital heart disease with any clinically significant<br> residual anatomic or conduction abnormality

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with PVI success;Number of subjects with PWI success;Physician feedback on FARAVIEW technology of the RHYTHMIA mapping system by means of a questionnaire