Status:
COMPLETED
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic cath...
Detailed Description
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter whe...
Eligibility Criteria
Inclusion
- Diagnosed with Symptomatic Paroxysmal AF.
- Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
- Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
- Age 18-75 years.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
- Signed Patient Informed Consent Form.
Exclusion
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF.
- Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
- Previously diagnosed with persistent, longstanding AF and/or continuous AF \> 7 days, or \> 48 hrs terminated by cardioversion.
- Any percutaneous coronary intervention (PCI) within the past 2 months.
- Valve repair or replacement and presence of a prosthetic valve.
- Any carotid stenting or endarterectomy.
- Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
- Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
- LA antero posterior diameter \> 50 mm
- Any PV with a diameter ≥ 26 mm
- Left Ventricular Ejection Fraction (LVEF) \< 40%.
- Contraindication to anticoagulation (e.g. heparin).
- History of blood clotting or bleeding abnormalities.
- Myocardial infarction within the past 2 months.
- Documented thromboembolic event \[including transient ischemic attack(TIA)\] within the past 12 months.
- Rheumatic Heart Disease.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Unstable angina.
- Acute illness or active systemic infection or sepsis.
- Diagnosed atrial myxoma or interatrial baffle or patch.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- Enrollment in an investigational study evaluating another device, biologic, or drug.
- Has known pulmonary vein stenosis.
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- Presence of an Inferior Vena Cava (IVC) filter
- Presence of a condition that precludes vascular access.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.
- Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being
- Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:
- Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03437733
Start Date
February 28 2018
End Date
October 17 2019
Last Update
June 29 2025
Active Locations (5)
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1
Na Homolce Hospital
Prague, Czechia
2
Ospedale "F. Miulli"
Bari, Italy
3
Centro Cardiologico Monzino
Milan, Italy
4
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom