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

November 11, 2021 updated by: Haukeland University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Tromsø, Norway
        • University Hospital of North Norway
      • Trondheim, Norway
        • St Olavs hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cryoballoon
Pulmonary vein isolation with cryoballoon catheter.
Procedure: Pulmonary vein isolation with cryoballoon catheter.
Device: Arctic Front Advance™ cardiac cryoablation catheter system.
Active Comparator: Radiofrequency
Pulmonary vein isolation with radiofrequency ablation catheter.
Procedure: Pulmonary vein isolation with radiofrequency ablation.
Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The freedom of any atrial arrhythmias at 12 months.
Time Frame: 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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure duration
Time Frame: 12 months
Procedure duration documented
12 months
Fluoroscopy time
Time Frame: 12 months
Fluoroscopy time documented
12 months
Ablation time
Time Frame: 12 months
Ablation time documented
12 months
Quality of life - Short Form (SF-36) Heath Survey
Time Frame: 12 months.
Short Form (SF-36) Heath Survey filled in by patients.
12 months.
Quality of life affected by atrial fibrillation.
Time Frame: 12 months.
The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.
12 months.
Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.
Time Frame: 12 months.
Hospitalization after the procedre
12 months.
The burden of atrial fibrillation
Time Frame: 12 months.
Total duration of atrial fibrillation recorded by 7-day Holter.
12 months.
The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.
Time Frame: 12 months.
Atrial tachycardia or atrial flutter recorded by all types of ECG
12 months.
Symptoms related to atrial fibrillation.
Time Frame: 12 months.
Symptoms related to atrial fibrillation documented
12 months.
Serious adverse events.
Time Frame: 12 months.
Serious adverse events documented
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

University Hospital of North Norway
St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 11, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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