CoolLoop Paroxysmal Atrial Fibrillation (CoolLoop PAF)

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Status: Terminated

Conditions: Atrial Fibrillation (Paroxysmal); Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases; Pathologic Processes

Treatments: Device: CoolLoop®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02553239

CoolLoop PAF

Details and patient eligibility

About

This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter.

A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 - 70 years
• symptomatic paroxysmal Atrial fibrillation (AF)
• a minimum of three episodes of paroxysmal AF
• at least one episode of paroxysmal AF within the last 6 months documented by ECG
• signed and dated informed consent documented by the patient
• female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation

Exclusion criteria

• left atrial diameter > 50 mm in the short axis as assessed by transthoracic echocardiography

• advanced structural heart disease including

  • moderate-to-severe valvular stenosis or regurgitation,
  • previous valve replacement or valve repair,
  • congenital heart disease,
  • left ventricular ejection fraction < 45% during sinus rhythm,
  • congestive heart failure New York Heart Association (NYHA) III or IV,
  • 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

• intolerance of Heparin and/or intolerance of oral anticoagulation

• previous AF ablation

• permanent pacemaker

• left atrial thrombus

• intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium

• access to the vascular system via the right or left femoral vein is not possible

• transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect)

• contraindication for transesophageal echocardiography or fluoroscopy

• impaired renal function (glomerular filtration rate <30 ml/min.)

• history or increased risk of intracranial hemorrhage

• history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment

• 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

• live-expectancy < 1 year

• the patient is active in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cryoablation

Experimental group

Description:

Cryoablation with the CoolLoop® catheter

Treatment:

Device: CoolLoop®