insufficient patient recruitment

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.

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