Back to resultsCryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cryoablation
Eligibility Criteria
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- Medical University Innsbruck
- AKH Linz
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cryoablation
Arm Description
Cryoablation
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
Acute Efficacy of Catheter Ablation
Absolute percentage of PVs isolated with the CoolLoop® catheter.
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.
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.
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.).
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.).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01687036
Brief Title
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Official Title
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
afreeze GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Cryoablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation
Arm Type
Other
Arm Description
Cryoablation
Intervention Type
Device
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cool Loop first, Cryoablation of Atrial Fibrillation
Intervention Description
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
3 months
Title
Tolerability of Ablation Using the AFreeze Cryoablation System
Description
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).
Time Frame
Treatment duration, up to 6 hours
Secondary Outcome Measure Information:
Title
Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.
Description
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.
Time Frame
Treatment Duration
Title
Acute Efficacy of Catheter Ablation
Description
Absolute percentage of PVs isolated with the CoolLoop® catheter.
Time Frame
Treatment Duration
Title
Clinical Efficacy of Catheter Ablation
Description
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.
Time Frame
First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
Title
Procedure Time
Description
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.
Time Frame
Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)
Title
Fluoroscopy Time
Description
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.).
Time Frame
Treatment Duration
Title
Cumulative Cryoablation Time
Description
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.).
Time Frame
First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
Title
AE
Description
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.
Time Frame
First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
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.
Exclusion Criteria:
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,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Stuehlinger, MD
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
AKH Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
12. IPD Sharing Statement
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Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
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