Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

NCT01687036 | Completed Results DMC

• 1 other identifier: CoolLoop First
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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).

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Cryoablation

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• 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).

  Treatment duration, up to 6 hours

Secondary Outcomes (7)

• Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.

  Treatment Duration

• Acute Efficacy of Catheter Ablation

  Treatment Duration

• Clinical Efficacy of Catheter Ablation

  First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013

• Procedure Time

  Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)

• Fluoroscopy Time

  Treatment Duration

Study Arms (1)

Cryoablation

OTHER

Cryoablation

Device: Cryoablation

Interventions

Cryoablation DEVICE

Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

Also known as: Cool Loop first, Cryoablation of Atrial Fibrillation

Cryoablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• afreeze GmbH: lead

Study Sites (2)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

AKH Linz

Linz, 4020, Austria

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Markus Stühlinger, MD
• Organization: Medical University Innsbruck, Department of Internal Medicine III, Cardiology

markus.stuehlinger@uki.at

+43 512 504

Study Officials

• Markus Stuehlinger, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: September 18, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 6, 2018
• Results First Posted: January 13, 2014

Record last verified: 2018-11

Locations

AU (2)