Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2014-07-31
2019-02-14
Brief Summary
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A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cryoablation
Cryoablation with the CoolLoop® catheter
CoolLoop®
Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System
Interventions
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CoolLoop®
Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Accovion GmbH
INDUSTRY
afreeze GmbH
OTHER
Responsible Party
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Principal Investigators
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Karoline Etschmaier, PhD
Role: STUDY_DIRECTOR
afreeze GmbH
Locations
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Medical University Innsbruck
Innsbruck, Tyrol, Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, Upper Austria, Austria
Klinik für Kardiologie
Bad Oeynhausen, North Rhine-Westphalia, Germany
UniversitätsSpital Zuerich
Zurich, , Switzerland
Countries
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Other Identifiers
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CoolLoop PAF
Identifier Type: -
Identifier Source: org_study_id
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