Clinical trial NCT02553239: CoolLoop Paroxysmal Atrial Fibrillation
Official title: CoolLoop Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation (Paroxysmal)
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Keywords: Atrial Fibrillation
Paroxysmal
Cryoablation
Lead sponsor: afreeze GmbH
Sponsor class: OTHER
Collaborators: name: Accovion GmbH
First posted: 2015-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.
timeFrame: 12 months follow-up period
Secondary outcomes:
measure: Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter.
timeFrame: from 3 to 12 months after catheter ablation
measure: Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation.
timeFrame: from start to end of ablation procedure
measure: Assessment of the CoolLoop catheter procedure time
timeFrame: from start to end of ablation procedure
measure: Assessment of the CoolLoop fluoroscopy time
timeFrame: from start to end of ablation procedure
measure: Assessment of the CoolLoop cryoablation time
timeFrame: from start to end of ablation procedure
measure: Assessment of serious and non-serious Adverse Events (SAEs/AEs)
timeFrame: 12 months follow-up period
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
state: Oberösterreich
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
city: Bad Oeynhausen
country: Germany
facility: Klinik für Kardiologie
state: Nordrhein-Westfalen
city: Zuerich
country: Switzerland
facility: UniversitätsSpital Zuerich
Study officials:
affiliation: afreeze GmbH
name: Karoline Etschmaier, PhD
role: STUDY_DIRECTOR
References: