Clinical trial NCT03818724: Treatment Success With the CoolLoop Cryoablation System
Official title: Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Keywords: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Cryoablation
Cryosurgery
Lead sponsor: afreeze GmbH
Sponsor class: OTHER
Collaborators: name: Raffeiner GmbH
First posted: 2019-01-28
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Incidence of serious adverse events
timeFrame: 36 months follow-up period
measure: Freedom from atrial fibrillation (efficacy) at 36 months post-ablation
timeFrame: 36 months follow-up period
Secondary outcomes:
measure: Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation
timeFrame: 12 and 24 months post-ablation
measure: Acute procedure success
timeFrame: 36 months follow-up period
measure: Total procedure time
timeFrame: Estimated timeframe up to 4 hours
measure: CoolLoop procedure time
timeFrame: Estimated timeframe up to 2 hours
measure: Total fluoroscopy time
timeFrame: Estimated time frame up to 1 hour
measure: CoolLoop fluoroscopy time
timeFrame: Estimated timeframe up to 30 minutes
measure: Cumulative cryoablation time
timeFrame: Estimated timeframe up to 1 hour
measure: Adverse Events (AEs) of special interest
timeFrame: 36 months follow-up period
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol/Austria
city: Neuwied
country: Germany
facility: Marienhaus Klinikum St. Elisabeth Neuwied
state: Germany/Rheinland-Pfalz
Study officials:
affiliation: afreeze GmbH
name: Andreas Kaiser, PhD
role: STUDY_DIRECTOR
affiliation: Medical University Innsbruck
name: Florian Hintringer, MD
role: PRINCIPAL_INVESTIGATOR
References: