CoolLoop Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter. A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.

Official Title
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CoolLoop Paroxysmal Atrial Fibrillation

Conditions
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Atrial Fibrillation (Paroxysmal), Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Pathologic Processes

Intervention / Treatment
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* Device: CoolLoop®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 - 70 years symptomatic paroxysmal Atrial fibrillation (AF) a minimum of three episodes of paroxysmal AF at least one episode of paroxysmal AF within the last 6 months documented by ECG signed and dated informed consent documented by the patient female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation Exclusion Criteria: left atrial diameter > 50 mm in the short axis as assessed by transthoracic echocardiography advanced structural heart disease including moderate-to-severe valvular stenosis or regurgitation, previous valve replacement or valve repair, congenital heart disease, left ventricular ejection fraction < 45% during sinus rhythm, congestive heart failure New York Heart Association (NYHA) III or IV, coronary artery bypass graft surgery within the last 3 months chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs severe respiratory insufficiency known bleeding diathesis intolerance of Heparin and/or intolerance of oral anticoagulation previous AF ablation permanent pacemaker left atrial thrombus intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium access to the vascular system via the right or left femoral vein is not possible transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect) contraindication for transesophageal echocardiography or fluoroscopy impaired renal function (glomerular filtration rate <30 ml/min.) history or increased risk of intracranial hemorrhage history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment severe comorbidity hyperthyreosis any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he / she were to participate in the study or confound the ability to interpret data from the study any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form pregnant or lactating females other severe conditions, which makes the patient unsuitable to participate in the study, as judged by the Investigator live-expectancy < 1 year the patient is active in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation<br>Cryoablation with the CoolLoop® catheter | Device: CoolLoop®<br>* Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System<br>* Other names: CoolLoop cryoablation system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events. |  | 12 months follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter. | Number of patients without AF episodes, determined by continuous ECG recording for 7 days at 1 year after treatment. | from 3 to 12 months after catheter ablation | 
| Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation. | Acute efficacy is defined as the electrical isolation in ≥ 3 PVs at the end of the intervention. Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | 
| Assessment of the CoolLoop catheter procedure time | Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | 
| Assessment of the CoolLoop fluoroscopy time | Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | 
| Assessment of the CoolLoop cryoablation time | Cryoablation time is specified as the cumulative total freeze time during treatment. Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | 
| Assessment of serious and non-serious Adverse Events (SAEs/AEs) | Number of patients with SAEs and AEs | 12 months follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Paroxysmal, Cryoablation