Status:
COMPLETED
Antral Lesions Characterization of a New Cryoballoon Ablation System in Terms of Local Impedance Drop
Lead Sponsor:
Maria Cecilia Hospital
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Brief Summary
Atrial fibrillation (AF) is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction. Electrocardiographic characte...
Eligibility Criteria
Inclusion
- Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center.
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
- Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of myxoma, LA ( left atrium) thrombus or intracardiac mural thrombus;
- Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG (Coronary artery bypass graft surgery ), PTCA ( Percutaneous transluminal coronary angioplasty), stent procedure) within 90 days prior to enrollment;
- Implantable cardiac device procedures ,e.g. PM (pacemaker), ICD( implantable cardioverter defibrillators), CRT within 30 days prior to enrollment;
- Implanted Left Atrial Appendage Closure device prior to the index procedure;
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;
- Subjects with severe valvular disease OR with a prosthetic - mechanical or biological
- \- heart valve (not including valve repair and annular rings);
- Presence of any pulmonary vein stents;
- Active systemic infection;
- Vena cava embolic protection filter devices and/ or known femoral thrombus;
- Any previous history of cryoglobulinemia;
- History of blood clotting or bleeding disease;
- Any prior history of documented cerebral infarct, TIA (transient ischemic attack) or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
- Subjects who are hemodynamically unstable or with structural heart disease;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Life expectancy ≤ 1 year per investigator's opinion;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion);
- Unrecovered/unresolved Adverse Events from any previous invasive Procedure;
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05410379
Start Date
September 15 2021
End Date
March 15 2023
Last Update
September 7 2023
Active Locations (1)
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1
MCH
Cotignola, Ravenna, Italy, 48033