Atrial Fibrillation (Paroxysmal)CoolLoop PAFNCT02553239
CoolLoop Paroxysmal Atrial Fibrillation
A study testing CoolLoop® in people with Atrial Fibrillation (Paroxysmal) and Arrhythmias, Cardiac, run by afreeze GmbH at 4 sites in 3 countries.
Trial summary
This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal), Arrhythmias, Cardiac, Cardiovascular Diseases
- What is being tested?
- CoolLoop®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2014to 14 Feb 2019
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 - 70 years
- symptomatic paroxysmal Atrial fibrillation (AF)
- a minimum of three episodes of paroxysmal AF
- at least one episode of paroxysmal AF within the last 6 months documented by ECG
- signed and dated informed consent documented by the patient
- female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation
Who cannot join
- left atrial diameter > 50 mm in the short axis as assessed by transthoracic echocardiography
- advanced structural heart disease including
- moderate-to-severe valvular stenosis or regurgitation,
- previous valve replacement or valve repair,
- congenital heart disease,
- left ventricular ejection fraction < 45% during sinus rhythm,
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- congestive heart failure New York Heart Association (NYHA) III or IV,
- coronary artery bypass graft surgery within the last 3 months
- chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs
- severe respiratory insufficiency
- known bleeding diathesis
- intolerance of Heparin and/or intolerance of oral anticoagulation
- previous AF ablation
- permanent pacemaker
- left atrial thrombus
- intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium
- access to the vascular system via the right or left femoral vein is not possible
- transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect)
- contraindication for transesophageal echocardiography or fluoroscopy
- impaired renal function (glomerular filtration rate <30 ml/min.)
- history or increased risk of intracranial hemorrhage
- history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment
- severe comorbidity
- hyperthyreosis
- any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he / she were to participate in the study or confound the ability to interpret data from the study
- any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form
- pregnant or lactating females
- other severe conditions, which makes the patient unsuitable to participate in the study, as judged by the Investigator
- live-expectancy < 1 year
- the patient is active in another clinical trial
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Austria2 sites
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Allgemeines Krankenhaus der Stadt Linz
Linz, Upper Austria, 4020
Germany1 site
Klinik für Kardiologie
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter.
A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.
- Conditions
- Atrial Fibrillation (Paroxysmal), Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Pathologic Processes
- Being tested
- CoolLoop®
- Keywords
- Atrial Fibrillation, Paroxysmal, Cryoablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolLoop®Device
Also called Cryoablation, CoolLoop cryoablation system
Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Cryoablation with the CoolLoop® catheter Receives: Device: CoolLoop® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.
Measured: 12 months follow-up period
Secondary outcomes (6)
Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter.
Number of patients without AF episodes, determined by continuous ECG recording for 7 days at 1 year after treatment.
Measured: from 3 to 12 months after catheter ablation
Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation.
Acute efficacy is defined as the electrical isolation in ≥ 3 PVs at the end of the intervention. Estimated timeframe 360 minutes (average).
Measured: from start to end of ablation procedure
Assessment of the CoolLoop catheter procedure time
Estimated timeframe 360 minutes (average).
Measured: from start to end of ablation procedure
Assessment of the CoolLoop fluoroscopy time
Estimated timeframe 360 minutes (average).
Measured: from start to end of ablation procedure
Assessment of the CoolLoop cryoablation time
Cryoablation time is specified as the cumulative "total freeze time" during treatment. Estimated timeframe 360 minutes (average).
Measured: from start to end of ablation procedure
Assessment of serious and non-serious Adverse Events (SAEs/AEs)
Number of patients with SAEs and AEs
Measured: 12 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 posted17 Sep 2015 (estimated)
- Study startJul 2014
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Why it stopped: insufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- afreeze GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Accovion GmbH
- Responsible party
- Sponsor
- Investigators
- Karoline Etschmaier, PhD, Study director, afreeze GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553239
- Sponsor's protocol ID
- CoolLoop PAF
- Acronym
- CoolLoop PAF
- Status last verified
- Mar 2019
- First submitted
- 14 Sep 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoolLoop Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02553239
- Acronym / sponsor ID
- CoolLoop PAF / CoolLoop PAF
- Conditions
- Atrial Fibrillation (Paroxysmal), Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Pathologic Processes
- Keywords
- Atrial Fibrillation, Paroxysmal, Cryoablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- afreeze GmbHUniversity, hospital or other
- Collaborators
- Accovion GmbH
- Study start
- Jul 2014
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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 investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter.
A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: CoolLoop®Cryoablation with the CoolLoop® catheter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 - 70 years
- symptomatic paroxysmal Atrial fibrillation (AF)
- a minimum of three episodes of paroxysmal AF
- at least one episode of paroxysmal AF within the last 6 months documented by ECG
- signed and dated informed consent documented by the patient
Key exclusion criteria (30 listed)
- left atrial diameter > 50 mm in the short axis as assessed by transthoracic echocardiography
- advanced structural heart disease including
- chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs
- severe respiratory insufficiency
- known bleeding diathesis
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®Also: Cryoablation, CoolLoop cryoablation systemCryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System | Device | Cryoablation |
Primary outcome
Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.
Time frame: 12 months follow-up period
6 secondary outcomes
Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter.
Time frame: from 3 to 12 months after catheter ablation
Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation.
Time frame: from start to end of ablation procedure
Assessment of the CoolLoop catheter procedure time
Time frame: from start to end of ablation procedure
Assessment of the CoolLoop fluoroscopy time
Time frame: from start to end of ablation procedure
Assessment of the CoolLoop cryoablation time
Time frame: from start to end of ablation procedure
Assessment of serious and non-serious Adverse Events (SAEs/AEs)
Time frame: 12 months follow-up period
Results and safety
The study was stopped early (reason given: insufficient patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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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.
Karoline Etschmaier, PhD study director
afreeze GmbH
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoolLoop® in people with Atrial Fibrillation (Paroxysmal) and Arrhythmias, Cardiac, run by afreeze GmbH at 4 sites in 3 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 6 inclusion and 30 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: stopped early, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany, Switzerland. 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?
The study was stopped early (reason given: insufficient patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events. (time frame: 12 months follow-up period). 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 15 Mar 2019.