Treatment Success With the CoolLoop Cryoablation System
1 other identifier
observational
540
2 countries
2
Brief Summary
This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop® cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months. A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2019
CompletedFirst Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJuly 21, 2022
July 1, 2022
6 years
January 21, 2019
July 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of serious adverse events
Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation
36 months follow-up period
Freedom from atrial fibrillation (efficacy) at 36 months post-ablation
Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation
36 months follow-up period
Secondary Outcomes (8)
Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation
12 and 24 months post-ablation
Acute procedure success
36 months follow-up period
Total procedure time
Estimated timeframe up to 4 hours
CoolLoop procedure time
Estimated timeframe up to 2 hours
Total fluoroscopy time
Estimated time frame up to 1 hour
- +3 more secondary outcomes
Study Arms (1)
CoolLoop® cryoablation system
Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system
Interventions
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
Eligibility Criteria
Patients have to be planned and be suitable for an ablation procedure. The decision to treat the patients with the CoolLoop® cryoablation System has already been made in advance by the Investigator. Informed consent has to be obtained before the ablation procedure.
You may qualify if:
- Age ≥ 18 years
- 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)
You may not qualify if:
- indication that the vascular system is not accessible through the left or right groin.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- afreeze GmbHlead
- Raffeiner GmbHcollaborator
Study Sites (2)
Medical University Innsbruck
Innsbruck, Tirol/Austria, 6020, Austria
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Germany/Rheinland-Pfalz, 56564, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andreas Kaiser, PhD
afreeze GmbH
- PRINCIPAL INVESTIGATOR
Florian Hintringer, MD
Medical University Innsbruck
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2019
First Posted
January 28, 2019
Study Start
January 17, 2019
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
July 21, 2022
Record last verified: 2022-07