NCT02553239

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

4.6 years

First QC Date

September 14, 2015

Last Update Submit

March 14, 2019

Conditions

Atrial Fibrillation (Paroxysmal)Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic Processes

Keywords

Atrial FibrillationParoxysmalCryoablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter.

    from 3 to 12 months after catheter ablation

  • Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation.

    from start to end of ablation procedure

  • Assessment of the CoolLoop catheter procedure time

    from start to end of ablation procedure

  • Assessment of the CoolLoop fluoroscopy time

    from start to end of ablation procedure

  • Assessment of the CoolLoop cryoablation time

    from start to end of ablation procedure

  • +1 more secondary outcomes

Study Arms (1)

Cryoablation

EXPERIMENTAL

Cryoablation with the CoolLoop® catheter

Device: CoolLoop®

Interventions

CoolLoop®DEVICE

Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System

Also known as: Cryoablation, CoolLoop cryoablation system
Cryoablation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Allgemeines Krankenhaus der Stadt Linz

Linz, Upper Austria, 4020, Austria

Location

Klinik für Kardiologie

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

UniversitätsSpital Zuerich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic Processes

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Karoline Etschmaier, PhD

    afreeze GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 17, 2015

Study Start

July 1, 2014

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

AU(2)DE(1)CH(1)