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Treatment Success With the CoolLoop Cryoablation System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 21, 2019
First Posted Date January 28, 2019
Last Update Posted Date July 21, 2022
Actual Study Start Date January 17, 2019
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 25, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Adverse Events (AEs) of special interest [ Time Frame: 36 months follow-up period ]
    Recording of AEs of Special interest and patient reported cardiac arrhythmias
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Success With the CoolLoop Cryoablation System
Official Title Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 36 Months
Biospecimen Not Provided
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.
Condition
  • Atrial Fibrillation
  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation
  • Arrhythmias, Cardiac
  • Cardiovascular Diseases
  • Heart Diseases
Intervention Device: CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
Study Groups/Cohorts CoolLoop® cryoablation system
Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system
Intervention: Device: CoolLoop® cryoablation system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 25, 2019)		 540
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Andreas Kaiser, PhD +43 (0) 69911073109 andreas.kaiser@afreeze.com
Contact: afreeze GmbH +43 (0) 512 209012 ext 0 clinical.research@afreeze.com
Listed Location Countries Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03818724
Other Study ID Numbers CooL-TreatS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party afreeze GmbH
Original Responsible Party Same as current
Current Study Sponsor afreeze GmbH
Original Study Sponsor Same as current
Collaborators Raffeiner GmbH
Investigators
Study Director: Andreas Kaiser, PhD afreeze GmbH
Principal Investigator: Florian Hintringer, MD Medical University Innsbruck
PRS Account afreeze GmbH
Verification Date July 2022