Atrial FibrillationNCT03818724
Treatment Success With the CoolLoop Cryoablation System
An observational study of Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by afreeze GmbH at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- CoolLoop® cryoablation system
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Jan 2019to Jan 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tirol/Austria, 6020
Florian Hintringer, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Germany/Rheinland-Pfalz, 56564
Burkhard Hügl, MD
About this study
Official title: Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
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.
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
- Being tested
- CoolLoop® cryoablation system
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryosurgery
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolLoop® cryoablation systemDevice
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
| Study group | Role | What they receive |
|---|---|---|
| CoolLoop® cryoablation system | Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system Receives: Device: CoolLoop® cryoablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation
Measured: 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
Measured: 36 months follow-up period
Secondary outcomes (8)
Freedom from atrial fibrillation (efficacy) at 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
Measured: 12 and 24 months post-ablation
Acute procedure success
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
Measured: 36 months follow-up period
Total procedure time
Total procedure time defined from introduction of the sheath until removal of the sheath
Measured: Estimated timeframe up to 4 hours
CoolLoop procedure time
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
Measured: Estimated timeframe up to 2 hours
Total fluoroscopy time
Total fluoroscopy time defined from introduction of the sheath until removal of the sheath
Measured: Estimated time frame up to 1 hour
CoolLoop fluoroscopy time
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
Measured: Estimated timeframe up to 30 minutes
Cumulative cryoablation time
Cumulative cryoablation time is displayed as "total freeze time" by the cryoconsole at the end of the procedure
Measured: Estimated timeframe up to 1 hour
Adverse Events (AEs) of special interest
Recording of AEs of Special interest and patient reported cardiac arrhythmias
Measured: 36 months follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start17 Jan 2019
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- afreeze GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Raffeiner GmbH
- Responsible party
- Sponsor
- Investigators
- Andreas Kaiser, PhD, Study director, afreeze GmbHFlorian Hintringer, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818724
- Sponsor's protocol ID
- CooL-TreatS
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance
- ClinicalTrials.gov ID
- NCT03818724
- Acronym / sponsor ID
- CooL-TreatS
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- afreeze GmbHUniversity, hospital or other
- Collaborators
- Raffeiner GmbH
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoolLoop® cryoablation system | – | Device: CoolLoop® cryoablation systemCryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolLoop® cryoablation systemCryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System | Device | CoolLoop® cryoablation system |
Primary outcome
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
8 secondary outcomes
Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation
Time frame: 12 and 24 months post-ablation
Acute procedure success
Time frame: 36 months follow-up period
Total procedure time
Time frame: Estimated timeframe up to 4 hours
CoolLoop procedure time
Time frame: Estimated timeframe up to 2 hours
Total fluoroscopy time
Time frame: Estimated time frame up to 1 hour
CoolLoop fluoroscopy time
Time frame: Estimated timeframe up to 30 minutes
Cumulative cryoablation time
Time frame: Estimated timeframe up to 1 hour
Adverse Events (AEs) of special interest
Time frame: 36 months follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kaiser, PhD study director
afreeze GmbH
Florian Hintringer, MD principal investigator
Medical University Innsbruck
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by afreeze GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Kaiser, PhD (+43 (0) 69911073109, andreas.kaiser@afreeze.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (time frame: 36 months follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.