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CoolLoop Paroxysmal Atrial Fibrillation (CoolLoop PAF)

Primary Purpose

Atrial Fibrillation (Paroxysmal), Arrhythmias, Cardiac, Cardiovascular Diseases

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CoolLoop®
Sponsored by
afreeze GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation (Paroxysmal) focused on measuring Atrial Fibrillation, Paroxysmal, Cryoablation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Allgemeines Krankenhaus der Stadt Linz
  • Medical University Innsbruck
  • Klinik für Kardiologie
  • UniversitätsSpital Zuerich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoablation

Arm Description

Cryoablation with the CoolLoop® catheter

Outcomes

Primary Outcome Measures

Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.

Secondary Outcome Measures

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.
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).
Assessment of the CoolLoop catheter procedure time
Estimated timeframe 360 minutes (average).
Assessment of the CoolLoop fluoroscopy time
Estimated timeframe 360 minutes (average).
Assessment of the CoolLoop cryoablation time
Cryoablation time is specified as the cumulative "total freeze time" during treatment. Estimated timeframe 360 minutes (average).
Assessment of serious and non-serious Adverse Events (SAEs/AEs)
Number of patients with SAEs and AEs

Full Information

First Posted
September 14, 2015
Last Updated
March 14, 2019
Sponsor
afreeze GmbH
Collaborators
Accovion GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02553239
Brief Title
CoolLoop Paroxysmal Atrial Fibrillation
Acronym
CoolLoop PAF
Official Title
CoolLoop Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
insufficient patient recruitment
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
afreeze GmbH
Collaborators
Accovion GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation (Paroxysmal), Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Pathologic Processes
Keywords
Atrial Fibrillation, Paroxysmal, Cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karoline Etschmaier, PhD
Organizational Affiliation
afreeze GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinik für Kardiologie
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
Facility Name
UniversitätsSpital Zuerich
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

CoolLoop Paroxysmal Atrial Fibrillation

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