Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

Not Applicable

Completed

Conditions: Atrial Fibrillation

Interventions: Device: Cryoablation

Registration Number: NCT01687036

Lead Sponsor: afreeze GmbH

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	Cryoablation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Acute Efficacy of Catheter Ablation	Treatment Duration	Absolute percentage of PVs isolated with the CoolLoop® catheter.
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.
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.).
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.).
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.