NCT04250714

Brief Summary

This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
7 countries

19 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 6, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 12, 2024

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

January 30, 2020

Results QC Date

June 5, 2023

Last Update Submit

March 27, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Safety Event Free Rate

    Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis

    12 months

  • Failure Free Rate

    includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure

    12 months

Secondary Outcomes (1)

  • Documentation and Rate of Acute Procedural Success

    Index Procedure

Study Arms (1)

Treatment patients

Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use

Device: Boston Scientific Cardiac Cryoablation System

Interventions

Boston Scientific Cardiac Cryoablation SystemDEVICE

cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins

Treatment patients

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients indicated for the treatment of AF with isolation of pulmonary veins technique according to current and future Guidelines and system indications for use

You may qualify if:

  • Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
  • Subjects who are willing and capable of providing informed consent;
  • Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;
  • Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

You may not qualify if:

  • Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
  • Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
  • Known or pre-existing severe Pulmonary Vein Stenosis;
  • Evidence of myxoma, LA thrombus or intracardiac mural thrombus;
  • Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment;
  • Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment;
  • Implanted Left Atrial Appendage Closure device prior to the index procedure;
  • Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;
  • Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
  • Presence of any pulmonary vein stents;
  • Active systemic infection;
  • Vena cava embolic protection filter devices and/ or known femoral thrombus;
  • Any previous history of cryoglobulinemia;
  • History of blood clotting or bleeding disease;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

UZ Brussel

Brussels, Belgium

Location

Klinicki Bolnicki Centar

Split, Croatia

Location

CHU De Brest - Hopital de la Cavale Blanche

Brest, France

Location

CHU De Caen

Caen, France

Location

CHU Grenoble - Hopital Michallon

Grenoble, France

Location

Clinique Pasteur

Toulouse, France

Location

CHRU Hospital Trousseau

Tours, France

Location

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

Location

Vivantes Klinikum Am Urban

Berlin, Germany

Location

Staedtisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Maria Cecilia Hospital SPA

Cotignola, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

Roma, Italy

Location

Erasmus MC

Rotterdam, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Related Publications (2)

  • Luik A, Anic A, Martin CA, Tilz RR, Yap SC, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Defaye P. One-Year Success Rates of a Stable, Low Pressure Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation: Results of the Prospective, International, Multicenter POLAR ICE Study. J Cardiovasc Electrophysiol. 2025 May;36(5):1046-1052. doi: 10.1111/jce.16645. Epub 2025 Mar 19.

    PMID: 40108686BACKGROUND

  • Martin CA, Tilz RRR, Anic A, Defaye P, Luik A, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Yap SC; POLAR ICE Investigators. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. doi: 10.1111/jce.15861. Epub 2023 Feb 23.

    PMID: 36786515RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Nele Cielen - Clinical Trial Manager
Organization
Boston Scientific
nele.cielen@bsci.com
0032470991143

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

August 6, 2020

Primary Completion

September 26, 2022

Study Completion

September 26, 2022

Last Updated

April 4, 2025

Results First Posted

February 12, 2024

Record last verified: 2025-03

Locations

IT(3)GB(3)FR(5)BE(1)CR(1)DE(4)NL(2)