Treatment Success With the CoolLoop Cryoablation System
NCT ID: NCT03818724
Last Updated: 2022-07-21
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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UNKNOWN
540 participants
OBSERVATIONAL
2019-01-17
2025-01-31
Brief Summary
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A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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CoolLoop® cryoablation system
Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system
CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
Interventions
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CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
Eligibility Criteria
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Inclusion Criteria
* atrial fibrillation: permanent AF excepted
* ECG documented AF within the last 6 months
* patients planned for an ablation procedure and suitable and planned for treatment with the CoolLoop® cryoablation system
* signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment (patient has received a copy of the ICF)
Exclusion Criteria
* indication that a transseptal puncture cannot be performed.
* any previous ablation or surgery due to AF.
* important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients.
* pregnant women at the time of the cryoablation procedure.
* any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
* participation in interventional trials for cardiovascular devices or drugs.
18 Years
ALL
No
Sponsors
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Raffeiner GmbH
INDUSTRY
afreeze GmbH
OTHER
Responsible Party
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Principal Investigators
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Andreas Kaiser, PhD
Role: STUDY_DIRECTOR
afreeze GmbH
Florian Hintringer, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University Innsbruck
Locations
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Medical University Innsbruck
Innsbruck, Tirol/Austria, Austria
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Germany/Rheinland-Pfalz, Germany
Countries
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Central Contacts
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Facility Contacts
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Florian Hintringer, MD
Role: primary
Burkhard Hügl, MD
Role: primary
Other Identifiers
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CooL-TreatS
Identifier Type: -
Identifier Source: org_study_id
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