Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System - Full Text View

Purpose

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 AE.

Condition	Intervention
Atrial Fibrillation	Device: Cryoablation

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by AFreeze GmbH:

Primary Outcome Measures:

Safety of ablation using the AFreeze Cryoablation System consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole Cryo-Caddy [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
- 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 consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole Cryo-Caddy [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
- 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 hemorr-hage 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.

Secondary Outcome Measures:

feasibility of catheter ablation [ Time Frame: 16 months ] [ Designated as safety issue: No ]
ability to position the catheter, forming the cryoapplicator to a loop, positioning and delivering cryothermia
acute efficacy of catheter ablation [ Time Frame: 16 months ] [ Designated as safety issue: No ]
percentage of electrodes without measureable signals
clinical efficacy of catheter ablation [ Time Frame: 16 months ] [ Designated as safety issue: No ]
no Atrial Fibrillation 4, 8 and 12 weeks after ablation
procedure time [ Time Frame: 16 months ] [ Designated as safety issue: No ]
time from introduction of the catheter into the left atrium until removal after termination of the last cryoapplication
fluoroscopy time [ Time Frame: 16 months ] [ Designated as safety issue: No ]
fluoroscopy time from introduction of the catheter into the left atrium until removal after termination of the last cryoapplication
cumulative cryoablation time [ Time Frame: 16 months ] [ Designated as safety issue: No ]
cumulative time of cryoablation
AE [ Time Frame: 16 months ] [ Designated as safety issue: No ]
onset and time course between visit 3 and 5 of pneumothorax,hemothorax,femoral pseudoaneurysm,arteriovenous fistulae,hemorrhage-no transfusion

Other Outcome Measures:

There are no other pre-specified outcome measures specified for this study. [ Time Frame: n.a. ] [ Designated as safety issue: No ]
n.a.

Estimated Enrollment:	10
Study Start Date:	September 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cryoablation Cryoablation	Device: Cryoablation Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System Other Names: Cryoablation Cool Loop first Cryoablation of Atrial Fibrillation

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 hemorr-hage requiring transfusion.49 - 51
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.

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 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 fistu-lae, hemorrhage not requiring transfusion.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687036

Locations

Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
AKH Linz
Linz, Austria, 4020

Sponsors and Collaborators

AFreeze GmbH

Investigators

Principal Investigator:

Markus Stuehlinger, MD

Medical University Innsbruck

More Information

No publications provided

Responsible Party:	AFreeze GmbH
ClinicalTrials.gov Identifier:	NCT01687036 History of Changes
Other Study ID Numbers:	CoolLoop First
Study First Received:	July 18, 2012
Last Updated:	May 13, 2013
Health Authority:	Austria: Federal Office for Safety in Health Care

Keywords provided by AFreeze GmbH:

Atrial fibrillation
Cryoablation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013