Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Cryoablation
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.
Interventions
DEVICECryoablation
Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Sponsors
afreeze GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy of Catheter Ablation | First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 | 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 | Average procedure time: 251 min. 06 sec. (range 126 - 320 min.) | 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. |
| Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System. | Treatment Duration | 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. |
| Cumulative Cryoablation Time | First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 | 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 | First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 | 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. |
| Fluoroscopy Time | Treatment Duration | 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.). |
| Acute Efficacy of Catheter Ablation | Treatment Duration | Absolute percentage of PVs isolated with the CoolLoop® catheter. |
Countries
Austria
Participant flow
Recruitment details
Recruitment period: September 3,2012 - December 14, 2012 Locations: Medical University Innsbruck, General Hospital Linz
Participants by arm
| Arm | Count |
|---|---|
| Cryoablation Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Cryoablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 57.6 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment Austria | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 6 / 10 |
Outcome results
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | 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) | 6 participants |
Primary
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).
Time frame: Treatment duration, up to 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | Tolerability of Ablation Using the AFreeze Cryoablation System | 1 AE (device related) |
Secondary
Acute Efficacy of Catheter Ablation
Absolute percentage of PVs isolated with the CoolLoop® catheter.
Time frame: Treatment Duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | Acute Efficacy of Catheter Ablation | 57.5 percentage of isolated PVs |
Secondary
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.
Time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | AE | 7 participants |
Secondary
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.
Time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | Clinical Efficacy of Catheter Ablation | 2 participants |
Secondary
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.).
Time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryoablation | Cumulative Cryoablation Time | 113.9 minutes | Standard Deviation 18.1 |
Secondary
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.
Time frame: Treatment Duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System. | 10 participants |
Secondary
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.).
Time frame: Treatment Duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryoablation | Fluoroscopy Time | 44 minutes | Standard Deviation 13.2 |
Secondary
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.
Time frame: Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryoablation | Procedure Time | 251.1 minutes | Standard Deviation 59.7 |