Atrial FibrillationNCT01687036
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
A study testing Cryoablation in people with Atrial Fibrillation, run by afreeze GmbH at 2 sites in Austria.
Trial summary
Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events (AEs). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustria
- Study dates
- Sep 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 AF, according to the actual guidelines of the Eu-ropean Society of Cardiology, despite treatment with at least one antiarr- hythmic drug
- at least one episode of AF within the last 3 months documented by ECG
- 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
- female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without in-terruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation (day 0, visit 3). This applies unless the subject commits to absolute and continued abstinence. The following are effective methods of contraception:
- Implant,
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- Levonorgestrel-releasing intrauterine system (IUS),
- Medroxyprogesterone acetate depot,
- Tubal sterilization,
- Sexual intercourse with a vasectomized male partner only; vasectomy must be confirmed by two negative semen ana-lyses,
- Ovulation inhibitory progesterone-only pills (i.e., desoge-strel). (Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception.
Who cannot join
- left atrial diameter > 50 mm as assessed by transthoracic echocardiogra-phy,
- electrical cardioversion performed later than seven days after onset of AF,
- advanced structural heart disease including
- moderate-to-severe valvular stenosis or regurgitation,
- previous myocardial infarction with impaired left ventricular systolic function,
- congenital heart disease,
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- left ventricular ejection fraction < 45% during sinus rhythm,
- 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 or intolerance of heparin or oral anticoagulation,
- previous AF ablation,
- left atrial thrombus,
- 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,
- the patient is active in another clinical trial.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Innsbruck
Innsbruck, 6020
AKH Linz
Linz, 4020
About this study
Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events (AEs).
Read the detailed description
Therefore, the primary endpoint will be a measurement of the following parameters and expressed in number of participants with AE:
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment)
- phrenic nerve palsy during visit 3 (treatment)- onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.
- onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and pulmonary vein (PV) stenosis requiring intervention.
Secondary Endpoint
The following parameters will be assessed and expressed in number of participants with AE/duration time:
- feasibility, defined by the ability to position the catheter in the proximal part in each of the PVs using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, position-ing the loop at the wall of the PV antrum and delivering cryothermia.
- acute efficacy of catheter ablation is defined as the percentage of electrodes within the PV without measureable signals.
- clinical efficacy of catheter ablation defined by freedom of Atrial Fibrillation (AF) four, eight and twelve weeks after ablation.
- procedure time defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryoapplication.
- fluoroscopy time defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryoapplication.
- cumulative cryoablation time.
- onset and time course between visit 3 (treatment) and visit 5 (discharge) of pneumothorax, hemothorax, femoral pseudoaneurysm, arteriovenous fistulae, hemorrhage not requiring transfusion.
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoablation
- Keywords
- Atrial fibrillation, Cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Also called Cool Loop first, Cryoablation of Atrial Fibrillation
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Other | Cryoablation Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)
The primary study objective is assessed by recording all Serious Adverse Events (SAEs).
Primary endpoint: measurement of the following parameters:
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).
- phrenic nerve palsy during visit 3 (treatment).
- onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.
- onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.
Measured: 3 months
Tolerability of Ablation Using the AFreeze Cryoablation System
The primary study objective is assessed by recording all Adverse Events (AEs).
Primary endpoint: measurement of the following parameters:
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).
Measured: Treatment duration, up to 6 hours
Secondary outcomes (7)
Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.
Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.
Measured: Treatment Duration
Acute Efficacy of Catheter Ablation
Absolute percentage of PVs isolated with the CoolLoop® catheter.
Measured: Treatment Duration
Clinical Efficacy of Catheter Ablation
During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.
Measured: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
Procedure Time
Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.
Measured: Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)
Fluoroscopy Time
Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.
Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.).
Measured: Treatment Duration
Cumulative Cryoablation Time
Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.
Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.).
Measured: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
AE
18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.
Measured: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- afreeze GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Stuehlinger, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687036
- Sponsor's protocol ID
- CoolLoop First
- Status last verified
- Nov 2018
- First submitted
- 18 Jul 2012
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
- ClinicalTrials.gov ID
- NCT01687036
- Acronym / sponsor ID
- CoolLoop First
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- afreeze GmbHUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events (AEs).
Detailed description
Therefore, the primary endpoint will be a measurement of the following parameters and expressed in number of participants with AE:
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment)
- phrenic nerve palsy during visit 3 (treatment)- onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.
- onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and pulmonary vein (PV) stenosis requiring intervention.
Secondary Endpoint
The following parameters will be assessed and expressed in number of participants with AE/duration time:
- feasibility, defined by the ability to position the catheter in the proximal part in each of the PVs using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, position-ing the loop at the wall of the PV antrum and delivering cryothermia.
- acute efficacy of catheter ablation is defined as the percentage of electrodes within the PV without measureable signals.
- clinical efficacy of catheter ablation defined by freedom of Atrial Fibrillation (AF) four, eight and twelve weeks after ablation.
- procedure time defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryoapplication.
- fluoroscopy time defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryoapplication.
- cumulative cryoablation time.
- onset and time course between visit 3 (treatment) and visit 5 (discharge) of pneumothorax, hemothorax, femoral pseudoaneurysm, arteriovenous fistulae, hemorrhage not requiring transfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Other | Device: CryoablationCryoablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age 18 - 70 years
- symptomatic paroxysmal AF, according to the actual guidelines of the Eu-ropean Society of Cardiology, despite treatment with at least one antiarr- hythmic drug
- at least one episode of AF within the last 3 months documented by ECG
- 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
- female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without in-terruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation (day 0, visit 3). This applies unless the subject commits to absolute and continued abstinence. The following are effective methods of contraception:
Key exclusion criteria (20 listed)
- left atrial diameter > 50 mm as assessed by transthoracic echocardiogra-phy,
- electrical cardioversion performed later than seven days after onset of AF,
- advanced structural heart disease including
- moderate-to-severe valvular stenosis or regurgitation,
- previous myocardial infarction with impaired left ventricular systolic function,
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 |
|---|---|---|
| CryoablationAlso: Cool Loop first, Cryoablation of Atrial FibrillationCryoablation of Atrial Fibrillation Using a Novel Cryoablation System | Device | Cryoablation |
Primary outcome
Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)
Time frame: 3 months
The primary study objective is assessed by recording all Serious Adverse Events (SAEs). Primary endpoint: measurement of the following parameters: * deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment). * phrenic nerve palsy during visit 3 (treatment). * onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion. * onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.
Tolerability of Ablation Using the AFreeze Cryoablation System
Time frame: Treatment duration, up to 6 hours
The primary study objective is assessed by recording all Adverse Events (AEs). Primary endpoint: measurement of the following parameters: - deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).
7 secondary outcomes
Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.
Time frame: Treatment Duration
Acute Efficacy of Catheter Ablation
Time frame: Treatment Duration
Clinical Efficacy of Catheter Ablation
Time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
Procedure Time
Time frame: Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)
Fluoroscopy Time
Time frame: Treatment Duration
Cumulative Cryoablation Time
Time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
AE
Time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Markus Stuehlinger, MD principal investigator
Medical University Innsbruck
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Atrial Fibrillation, run by afreeze GmbH at 2 sites in Austria.
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 11 inclusion and 20 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: finished, as of the sponsor's last update on 6 Dec 2018. 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. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs) (time frame: 3 months). 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 6 Dec 2018.