Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AFreeze GmbH
ClinicalTrials.gov Identifier:
NCT01687036
First received: July 18, 2012
Last updated: November 25, 2013
Last verified: November 2013
  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 Adverse Events (AEs).


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:


Further study details as provided by AFreeze GmbH:

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) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: Treatment Duration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment Duration ] [ Designated as safety issue: No ]
    Absolute percentage of PVs isolated with the CoolLoop® catheter.

  • Clinical Efficacy of Catheter Ablation [ Time Frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average procedure time: 251 min. 06 sec. (range 126 - 320 min.) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment Duration ] [ Designated as safety issue: No ]

    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 [ Time Frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 ] [ Designated as safety issue: No ]

    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 [ Time Frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 10
Study Start Date: September 2012
Study Completion Date: June 2013
Primary Completion Date: March 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 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.
  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: July 19, 2013
Last Updated: November 25, 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 July 20, 2014