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Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation (IRON-ICE)

Primary Purpose

Persistent Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiofrequency Ablation
Cryoballoon ablation
Sponsored by
Luigi Sacco University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Persistent atrial fibrillation, Catheter ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
  2. Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure
  3. Age range of 18 - 85 years
  4. Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead.
  5. Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria:

  • Congenital heart disease, age younger than 18 years, significant valve disease, LA size >55 mm, and severe heart failure (ejection fraction < 30% and/or New York Heart Association class IV).
  • Presence of a mechanical prosthetic valve.
  • Secondary causes of atrial fibrillation
  • Documented intra-atrial thrombus or another abnormality which precludes catheter introduction.
  • Social factors that would preclude follow up or make compliance difficult.-
  • Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.

Sites / Locations

  • Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"Recruiting
  • Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
  • Istituto Clinico S. Ambrogio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cryoballoon ablation

Radiofrequency Ablation

Arm Description

Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.

Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.

Outcomes

Primary Outcome Measures

Freedom from atrial tachycardia/fibrillation
Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.

Secondary Outcome Measures

Number of AF episodes recorded.
Duration of AF episodes recorded.
Length of postoperative hospital stay.
Total procedural time.
Fluoroscopy time
Left atrial instrumentation time
total time during which there are catheters in the LA
Hospitalizations after discharge.
number of hospitalizations after discharge
Procedure-related complications
Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
Incidence of cerebrovascular events from the time of the operation up to 90 days.
Long-term success
freedom from AF/AFL/AT recurrences following the 3-month blanking period within 36-month follow-up from the date of the ablation procedure in the absence of Class I and III antiarrhythmic drug therapy.
Freedom from clinical or stroke-relevant AF/AFL/AT.
Freedom from AF/AFL/AT with duration cutoff > 1 hour
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)
Freedom from AF/AFL/AT with duration cutoff > 7 days
Regression from persistent to non-paroxysmal atrial fibrillation
Patients converted into paroxysmal forms of AF.
Significant reduction in AF burden
>75% reduction from pre- to postablation and/or total postablation burden <12%
Low daily AF burden
Patients with AF burden less than 1%- 2%
Death from any cause

Full Information

First Posted
November 17, 2017
Last Updated
February 21, 2018
Sponsor
Luigi Sacco University Hospital
Collaborators
Centro Cardiologico Monzino
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1. Study Identification

Unique Protocol Identification Number
NCT03365700
Brief Title
Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
Acronym
IRON-ICE
Official Title
Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luigi Sacco University Hospital
Collaborators
Centro Cardiologico Monzino

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation. The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Persistent atrial fibrillation, Catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryoballoon ablation
Arm Type
Active Comparator
Arm Description
Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.
Arm Title
Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Other Intervention Name(s)
Pulmonary vein isolation
Intervention Description
Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
Intervention Type
Procedure
Intervention Name(s)
Cryoballoon ablation
Other Intervention Name(s)
Pulmonary vein isolation
Intervention Description
Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.
Primary Outcome Measure Information:
Title
Freedom from atrial tachycardia/fibrillation
Description
Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of AF episodes recorded.
Time Frame
12 months
Title
Duration of AF episodes recorded.
Time Frame
12 months
Title
Length of postoperative hospital stay.
Time Frame
1 month
Title
Total procedural time.
Time Frame
1 day
Title
Fluoroscopy time
Time Frame
1 day
Title
Left atrial instrumentation time
Description
total time during which there are catheters in the LA
Time Frame
1 day
Title
Hospitalizations after discharge.
Description
number of hospitalizations after discharge
Time Frame
12 months
Title
Procedure-related complications
Description
Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
Time Frame
1 week
Title
Incidence of cerebrovascular events from the time of the operation up to 90 days.
Time Frame
90 Days
Title
Long-term success
Description
freedom from AF/AFL/AT recurrences following the 3-month blanking period within 36-month follow-up from the date of the ablation procedure in the absence of Class I and III antiarrhythmic drug therapy.
Time Frame
36 months
Title
Freedom from clinical or stroke-relevant AF/AFL/AT.
Description
Freedom from AF/AFL/AT with duration cutoff > 1 hour
Time Frame
12 months
Title
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)
Description
Freedom from AF/AFL/AT with duration cutoff > 7 days
Time Frame
12 months
Title
Regression from persistent to non-paroxysmal atrial fibrillation
Description
Patients converted into paroxysmal forms of AF.
Time Frame
12 months
Title
Significant reduction in AF burden
Description
>75% reduction from pre- to postablation and/or total postablation burden <12%
Time Frame
12 months
Title
Low daily AF burden
Description
Patients with AF burden less than 1%- 2%
Time Frame
12 months
Title
Death from any cause
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure Age range of 18 - 85 years Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead. Patients must be able and willing to provide written informed consent to participate in the clinical trial. Exclusion Criteria: Congenital heart disease, age younger than 18 years, significant valve disease, LA size >55 mm, and severe heart failure (ejection fraction < 30% and/or New York Heart Association class IV). Presence of a mechanical prosthetic valve. Secondary causes of atrial fibrillation Documented intra-atrial thrombus or another abnormality which precludes catheter introduction. Social factors that would preclude follow up or make compliance difficult.- Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni B Forleo, MD, PhD
Phone
+390239042789
Email
gbforleo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Tondo, MD, PhD
Organizational Affiliation
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni B Forleo, MD, PhD
Email
gbforleo@gmail.com
Facility Name
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Tondo, Professor
First Name & Middle Initial & Last Name & Degree
Gaetano Fassini, MD
Facility Name
Istituto Clinico S. Ambrogio
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Mantica, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27381589
Citation
Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
Results Reference
result
PubMed Identifier
27042964
Citation
Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
Results Reference
result

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Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

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