CoolLoop Paroxysmal Atrial Fibrillation (CoolLoop PAF)

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.

Study Overview

• Status: Terminated
• Conditions: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation (Paroxysmal)
• Intervention / Treatment: Device: CoolLoop®

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Allgemeines Krankenhaus der Stadt Linz
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medical University Innsbruck
• Germany
  • Nordrhein-Westfalen
    • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Klinik für Kardiologie
• Switzerland
  • Zuerich, Switzerland, 8091
    • Universitätsspital Zuerich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoablation; Cryoablation with the CoolLoop® catheter	Device: CoolLoop®; Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System; Other Names: Cryoablation; CoolLoop cryoablation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Assessment of the CoolLoop catheter procedure time	Estimated timeframe 360 minutes (average).	from start to end of ablation procedure
Assessment of the CoolLoop fluoroscopy time	Estimated timeframe 360 minutes (average).	from start to end of ablation procedure
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
Assessment of serious and non-serious Adverse Events (SAEs/AEs)	Number of patients with SAEs and AEs	12 months follow-up period

Collaborators and Investigators

• Sponsor: afreeze GmbH
• Collaborators: Accovion GmbH
• Investigators: Study Director: Karoline Etschmaier, PhD, afreeze GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cryoablation; Paroxysmal
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Pathologic Processes
• Other Study ID Numbers: CoolLoop PAF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No