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Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Holter monitoring
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryoballoon, Pulmonary Vein Isolation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as:

    • Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR
    • Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording
  • Date of first diagnosis of persistent AF within the last 12 months preceding the consent date
  • Age between 18 and 75 years
  • Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study

Exclusion Criteria:

  • Long-standing persistent AF (has lasted for ≥1 year)
  • Current diagnosis of paroxysmal AF
  • Anteroposterior LA diameter > 5.0 cm by TTE
  • Current intracardiac thrombus
  • Presence of one or more pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Primary pulmonary hypertension
  • NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measure by acceptable cardiac testing (e.g. TTE)
  • Hypertrophic cardiomyopathy
  • Previous LA ablation or surgery
  • Unstable angina
  • Presence of any cardiac valve prosthesis
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
  • Cryoglobulinemia
  • Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
  • Uncontrolled hyperthyroidism
  • Any woman known to be pregnant or breastfeeding
  • Active systemic infection
  • Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators
  • Life expectancy ≤ 1 year
  • Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager
  • Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)

Sites / Locations

  • Hôpital Henri Mondor
  • CHU de Grenoble
  • CHU de la Timone
  • CHU - Hôpitaux de Rouen
  • Clinique Pasteur
  • Herz- und Diabeteszentrum NRW
  • Charite - Universitaetsmedizin
  • Cardioangiologisches Centrum Bethanien
  • Asklepios Klinik St. Georg
  • Krankenhaus Porz am Rhein
  • St. Vinzenz-Hospital
  • Klinikum Nürnberg Süd
  • Uniklinik Ulm
  • Henry Dunant Hospital Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cryoballoon ablation

Arm Description

Subjects will wear holter monitors at baseline, 6 months and 12 months

Outcomes

Primary Outcome Measures

Single procedure success of cryoballoon ablation on patients with early persistent AF
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.

Secondary Outcome Measures

Acute procedural success of cryoballoon ablation on patients with early persistent AF
Acute procedural success is defined as: Only Arctic Front Advance catheters used to achieve procedure success AND All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)
Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve multiple procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
Sinus rhythm restoration being followed by chronic prevention of AF recurrence
Use of class I and class III antiarrhythmic drugs
Changes in quality of life measurements between baseline, 6 months and 12 months after procedure
Adverse events required to be collected during the study

Full Information

First Posted
July 31, 2014
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02213731
Brief Title
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
Official Title
Cryoballoon Ablation for Early Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 8, 2014 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
September 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryoballoon, Pulmonary Vein Isolation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cryoballoon ablation
Arm Type
Other
Arm Description
Subjects will wear holter monitors at baseline, 6 months and 12 months
Intervention Type
Other
Intervention Name(s)
Holter monitoring
Intervention Description
Subjects will wear holter monitors at baseline, 6 months and 12 months.
Primary Outcome Measure Information:
Title
Single procedure success of cryoballoon ablation on patients with early persistent AF
Description
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Acute procedural success of cryoballoon ablation on patients with early persistent AF
Description
Acute procedural success is defined as: Only Arctic Front Advance catheters used to achieve procedure success AND All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)
Time Frame
Post-procedure
Title
Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)
Description
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve multiple procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
Time Frame
12 months
Title
Sinus rhythm restoration being followed by chronic prevention of AF recurrence
Time Frame
12 months
Title
Use of class I and class III antiarrhythmic drugs
Time Frame
12 months
Title
Changes in quality of life measurements between baseline, 6 months and 12 months after procedure
Time Frame
Baseline, 6 months, 12 months
Title
Adverse events required to be collected during the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as: Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording Date of first diagnosis of persistent AF within the last 12 months preceding the consent date Age between 18 and 75 years Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study Exclusion Criteria: Long-standing persistent AF (has lasted for ≥1 year) Current diagnosis of paroxysmal AF Anteroposterior LA diameter > 5.0 cm by TTE Current intracardiac thrombus Presence of one or more pulmonary vein stents Presence of any pre-existing pulmonary vein stenosis Primary pulmonary hypertension NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measure by acceptable cardiac testing (e.g. TTE) Hypertrophic cardiomyopathy Previous LA ablation or surgery Unstable angina Presence of any cardiac valve prosthesis Thrombocytosis, thrombocytopenia Any condition contraindicating chronic anticoagulation Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date Cryoglobulinemia Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months Uncontrolled hyperthyroidism Any woman known to be pregnant or breastfeeding Active systemic infection Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators Life expectancy ≤ 1 year Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Boveda, M.D.
Organizational Affiliation
Clinique Pasteur
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Defaye, M.D.
Organizational Affiliation
CHU Michallo, Unité de Rythmologie, Clinique de cardiologie, CHU de Grenoble site Nord - Hôpital Albert Michallon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHU de la Timone
City
Marseille Cedex
Country
France
Facility Name
CHU - Hôpitaux de Rouen
City
Rouen Cedex
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
Country
Germany
Facility Name
Charite - Universitaetsmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
Country
Germany
Facility Name
Krankenhaus Porz am Rhein
City
Köln
Country
Germany
Facility Name
St. Vinzenz-Hospital
City
Köln
Country
Germany
Facility Name
Klinikum Nürnberg Süd
City
Nürnberg
Country
Germany
Facility Name
Uniklinik Ulm
City
Ulm
Country
Germany
Facility Name
Henry Dunant Hospital Center
City
Athens
ZIP/Postal Code
11526
Country
Greece

12. IPD Sharing Statement

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Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)

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