CoolLoop Paroxysmal Atrial Fibrillation

Cardiovascular Diseases Clinical Trial

— CoolLoop PAF  

Official title:

CoolLoop Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02553239
• Other study ID #: CoolLoop PAF
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: February 14, 2019

Study information

• Verified date: March 2019
• Source: AFreeze GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation (Paroxysmal)
• Cardiovascular Diseases
• Heart Diseases
• Pathologic Processes

Intervention

Device:
• CoolLoop®
Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz	Oberösterreich
Germany	Klinik für Kardiologie	Bad Oeynhausen	Nordrhein-Westfalen
Switzerland	UniversitätsSpital Zuerich	Zuerich

Sponsors (2)

Lead Sponsor	Collaborator
AFreeze GmbH	Accovion GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.		12 months follow-up period
Secondary	Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter.	Number of patients without AF episodes, determined by continuous ECG recording for 7 days at 1 year after treatment.	from 3 to 12 months after catheter ablation
Secondary	Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation.	Acute efficacy is defined as the electrical isolation in = 3 PVs at the end of the intervention. Estimated timeframe 360 minutes (average).	from start to end of ablation procedure
Secondary	Assessment of the CoolLoop catheter procedure time	Estimated timeframe 360 minutes (average).	from start to end of ablation procedure
Secondary	Assessment of the CoolLoop fluoroscopy time	Estimated timeframe 360 minutes (average).	from start to end of ablation procedure
Secondary	Assessment of the CoolLoop cryoablation time	Cryoablation time is specified as the cumulative "total freeze time" during treatment. Estimated timeframe 360 minutes (average).	from start to end of ablation procedure
Secondary	Assessment of serious and non-serious Adverse Events (SAEs/AEs)	Number of patients with SAEs and AEs	12 months follow-up period