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Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pulmonary vein isolation with cryoballoon catheter.
Pulmonary vein isolation with radiofrequency ablation.
Sponsored by
Haukeland 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 Atrial Fibrillation, Catheter Ablation

Eligibility Criteria

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

Inclusion criteria:

  • Patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (>7 days) and longstanding persistent atrial fibrillation (> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion.
  • Subject is at least 18 and ≤ 75 years old.
  • Subject is able and willing to give informed consent.

Exclusion criteria:

  • Subject has paroxysmal atrial fibrillation (< 7days) or persistent atrial fibrillation with duration > 3 years.
  • Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation.
  • Subject has presence of an intracavitary thrombus.
  • Subject has uncontrolled heart failure.
  • Subject has severe valvular disease.
  • Subject has the left atrial diameter > 60 mm confirmed by echocardiography.
  • Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants.
  • Subject has known cryoglobulinaemia.
  • Subject has severe renal dysfunction.
  • Subject who is or may potentially be pregnant.
  • Subject has unstable angina pectoris.
  • Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
  • Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.

Sites / Locations

  • Haukeland University Hospital
  • University Hospital of North Norway
  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cryoballoon

Radiofrequency

Arm Description

Pulmonary vein isolation with cryoballoon catheter.

Pulmonary vein isolation with radiofrequency ablation catheter.

Outcomes

Primary Outcome Measures

The freedom of any atrial arrhythmias at 12 months.
The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration > 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).

Secondary Outcome Measures

Procedure duration
Procedure duration documented
Fluoroscopy time
Fluoroscopy time documented
Ablation time
Ablation time documented
Quality of life - Short Form (SF-36) Heath Survey
Short Form (SF-36) Heath Survey filled in by patients.
Quality of life affected by atrial fibrillation.
The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.
Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.
Hospitalization after the procedre
The burden of atrial fibrillation
Total duration of atrial fibrillation recorded by 7-day Holter.
The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.
Atrial tachycardia or atrial flutter recorded by all types of ECG
Symptoms related to atrial fibrillation.
Symptoms related to atrial fibrillation documented
Serious adverse events.
Serious adverse events documented

Full Information

First Posted
November 23, 2016
Last Updated
November 11, 2021
Sponsor
Haukeland University Hospital
Collaborators
St. Olavs Hospital, University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT03008811
Brief Title
Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation
Acronym
NO PERS-AF
Official Title
Norwegian Randomized Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
St. Olavs Hospital, University Hospital of North Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.
Detailed Description
The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
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
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoballoon
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation with cryoballoon catheter.
Arm Title
Radiofrequency
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation with radiofrequency ablation catheter.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation with cryoballoon catheter.
Intervention Description
Device: Arctic Front Advance™ cardiac cryoablation catheter system.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation with radiofrequency ablation.
Intervention Description
Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
Primary Outcome Measure Information:
Title
The freedom of any atrial arrhythmias at 12 months.
Description
The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration > 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedure duration
Description
Procedure duration documented
Time Frame
12 months
Title
Fluoroscopy time
Description
Fluoroscopy time documented
Time Frame
12 months
Title
Ablation time
Description
Ablation time documented
Time Frame
12 months
Title
Quality of life - Short Form (SF-36) Heath Survey
Description
Short Form (SF-36) Heath Survey filled in by patients.
Time Frame
12 months.
Title
Quality of life affected by atrial fibrillation.
Description
The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.
Time Frame
12 months.
Title
Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.
Description
Hospitalization after the procedre
Time Frame
12 months.
Title
The burden of atrial fibrillation
Description
Total duration of atrial fibrillation recorded by 7-day Holter.
Time Frame
12 months.
Title
The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.
Description
Atrial tachycardia or atrial flutter recorded by all types of ECG
Time Frame
12 months.
Title
Symptoms related to atrial fibrillation.
Description
Symptoms related to atrial fibrillation documented
Time Frame
12 months.
Title
Serious adverse events.
Description
Serious adverse events documented
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 plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (>7 days) and longstanding persistent atrial fibrillation (> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion. Subject is at least 18 and ≤ 75 years old. Subject is able and willing to give informed consent. Exclusion criteria: Subject has paroxysmal atrial fibrillation (< 7days) or persistent atrial fibrillation with duration > 3 years. Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation. Subject has presence of an intracavitary thrombus. Subject has uncontrolled heart failure. Subject has severe valvular disease. Subject has the left atrial diameter > 60 mm confirmed by echocardiography. Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants. Subject has known cryoglobulinaemia. Subject has severe renal dysfunction. Subject who is or may potentially be pregnant. Subject has unstable angina pectoris. Subject has history of previous myocardial infarction or percutaneous intervention during the last three months. Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
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Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation

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