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Treatment Success With the CoolLoop Cryoablation System

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ClinicalTrials.gov Identifier: NCT03818724
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
afreeze GmbH

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Atrial Fibrillation Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Device: CoolLoop® cryoablation system

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 540 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
CoolLoop® cryoablation system
Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system
 Device: CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: 36 months follow-up period ]
    Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation

  2. Freedom from atrial fibrillation (efficacy) at 36 months post-ablation [ Time Frame: 36 months follow-up period ]
    Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation


Secondary Outcome Measures :
  1. Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation [ Time Frame: 12 and 24 months post-ablation ]
    Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 12 and 24 months post-ablation

  2. Acute procedure success [ Time Frame: 36 months follow-up period ]
    Acute efficacy of isolation of each of the pulmonary veins defined as the percentage of diagnostic mapping catheter electrode pairs within the pulmonary vein without any detectable pulmonary vein signal in case of redo procedure

  3. Total procedure time [ Time Frame: Estimated timeframe up to 4 hours ]
    Total procedure time defined from introduction of the sheath until removal of the sheath

  4. CoolLoop procedure time [ Time Frame: Estimated timeframe up to 2 hours ]
    CoolLoop procedure time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after Termination of the last cryo-application with the CoolLoop cryoablation catheter

  5. Total fluoroscopy time [ Time Frame: Estimated time frame up to 1 hour ]
    Total fluoroscopy time defined from introduction of the sheath until removal of the sheath

  6. CoolLoop fluoroscopy time [ Time Frame: Estimated timeframe up to 30 minutes ]
    CoolLoop fluoroscopy time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after termination of the last cryo-application with the CoolLoop cryoablation catheter

  7. Cumulative cryoablation time [ Time Frame: Estimated timeframe up to 1 hour ]
    Cumulative cryoablation time is displayed as "total freeze time" by the cryoconsole at the end of the procedure

  8. Adverse Events (AEs) of special interest [ Time Frame: 36 months follow-up period ]
    Recording of AEs of Special interest and patient reported cardiac arrhythmias


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818724


Contacts
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Contact: Andreas Kaiser, PhD +43 (0) 69911073109 andreas.kaiser@afreeze.com
Contact: afreeze GmbH +43 (0) 512 209012 ext 0 clinical.research@afreeze.com

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Tirol/Austria, Austria, 6020
Contact: Florian Hintringer, MD         
Germany
Marienhaus Klinikum St. Elisabeth Neuwied Not yet recruiting
Neuwied, Germany/Rheinland-Pfalz, Germany, 56564
Contact: Burkhard Hügl, MD         
Sponsors and Collaborators
afreeze GmbH
Raffeiner GmbH
Investigators
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Study Director: Andreas Kaiser, PhD afreeze GmbH
Principal Investigator: Florian Hintringer, MD Medical University Innsbruck
More Information
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Additional Information:

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Responsible Party: afreeze GmbH
ClinicalTrials.gov Identifier: NCT03818724    
Other Study ID Numbers: CooL-TreatS
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by afreeze GmbH:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Cryoablation
Cryosurgery
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes