Back to resultsiCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Primary Purpose
Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
cryoablation procedure using the iCLAS Cryoablation System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years of age
- Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System
- Subject willing to comply with study requirements and give informed consent.
Exclusion Criteria:
- In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU).
- Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor.
- Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)
Sites / Locations
- Onze-Lieve-Vrouw Hospital Aalst (OLV)Recruiting
- Universitatsklinikum ErlangenRecruiting
- St. Antonius ZiekenhuisRecruiting
- Erasmus MCRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
iCLAS Cryoablation arm
Arm Description
all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month
Outcomes
Primary Outcome Measures
Primary outcome - freedom from AF
Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.
Primary outcome - freedom from AF/AT/AFL
Freedom from Atrial Arrhythmia at 12-months
Primary outcome - freedom from Device/Procedure Related Adverse Events
Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416086
Brief Title
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Official Title
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2021 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adagio Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
Detailed Description
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iCLAS Cryoablation arm
Arm Type
Other
Arm Description
all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month
Intervention Type
Device
Intervention Name(s)
cryoablation procedure using the iCLAS Cryoablation System
Intervention Description
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
Primary Outcome Measure Information:
Title
Primary outcome - freedom from AF
Description
Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.
Time Frame
12 months
Title
Primary outcome - freedom from AF/AT/AFL
Description
Freedom from Atrial Arrhythmia at 12-months
Time Frame
12 months
Title
Primary outcome - freedom from Device/Procedure Related Adverse Events
Description
Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up
Time Frame
during procedure and up to 12-month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years of age
Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System
Subject willing to comply with study requirements and give informed consent.
Exclusion Criteria:
In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU).
Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor.
Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil M Jubran
Phone
(949) 348-1188
Email
njubran@adagiomedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Doug Kurschinski
Phone
(949) 348-1188
Email
dkurschinski@adagiomedical.com
Facility Information:
Facility Name
Onze-Lieve-Vrouw Hospital Aalst (OLV)
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom de Potter, MD
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Anneken, MD
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Boersma, MD
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamas Szili-Torok, MD
First Name & Middle Initial & Last Name & Degree
Tamas Szili-Torok
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
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