Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (SCALAF)

May 15, 2017 updated by: Medtronic Bakken Research Center

Surgical or Catheter Ablations in Patients With Lone Atrial Fibrillation: Determination of Acute and Long Term Success Rate (SCALAF Success Trial)

Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable monitoring device).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Title: Surgical or Catheter Ablation in patients with Lone Atrial Fibrillation: determination of acute and long term SUCCESS (SCALAF-success trial).

Background: Anti-arrhythmic drugs are used in daily practice to treat patients with paroxysmal idiopatic AF. Often the origin of the AF can be found in the muscle sleeves running up the pulmonary veins. Drug treatment is not always successful and prone to evoke negative side effects. The surgical MAZE procedure was applied in the past, but this is a time consuming, cumbersome technique, often associated with significant complications. Cardiac radio-frequency ablation offers an alternative, easy and less time consuming treatment: lesions prevent normal electrical wave front propagation and might stop the continuation of atrial fibrillation wave fronts. Ablation can be implemented by use of special catheters inserted via the groin or using the Medtronic Cardioblate® Surgical Ablation System applied via minimal invasive surgical techniques.

Purpose: Compare the effectiveness of pulmonary vein isolation achieved via catheter or via surgical ablation techniques to treat patients with paroxysmal lone AF.

Study design: A prospective, randomized multi-center interventional study.

Patients: Patients suffering from paroxysmal idiopatic AF (no associated or underlying structural heart disease) complying with following inclusion criteria:

  • minimally one documented AF-episode in the last 6 months;
  • refractory to at least 2 class I or III anti-arrhythmic drugs;
  • age > 18 year

Intervention: Patients are randomized to either the surgical or the catheter ablation group and receive the indicated treatment. During the critical assessment period, the patients are weaned from anti-arrhythmic medication.

Primary endpoint: Reduction in AF occurrence measured by the AF-burden parameter in the critical period between 3 and 6 months post-ablation. AF burden is measured automatically by means of the Reveal XT, implanted at study enrolment to document the baseline characteristics.

Secondary endpoints:

  • Failure of therapy requiring re-interventions;
  • Duration, burden and costs of ablation procedures:
  • Reduction in frequency, duration and level of severity of AF symptoms;
  • Occurences of treatments of arrythmic episodes;
  • Assessment of AF burden during follow-up period
  • Symptoms associated with AF;
  • Reduced necessity of anti-arrhythmic or anticoagulant medication;
  • Left atrial dimensions and contractility
  • Adverse events associated with the ablation therapy;
  • Occurrence of other clinical adverse events (TIA, CVA, bleeds, tamponade, MI) at 3, 6, 12 and 24 months of follow up
  • Mortality and hospitalisation

Risk assessment: Possible side effects : irregular heart rhythm, pericardial fluid, stroke, heart infarct, disturbances of the conduction system in the heart, local pain at the site of incisions, heart failure or reduced pump function of the heart.

Possible benefits: Regulation of the heart rhythm without applying MAZE procedure or opening of the thorax. Reduction or relief from symptoms associated with AF. Partial or complete reduction of anti-arrhythmic medication. Control of anti-coagulant medication. Improved quality of life for the patients.

Visits are planned at study entrance and Reveal XT implant (assessment at baseline, application of the ablation therapy), discharge from hospital, and at 3, 6, 12 and 24 months post-ablation.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Netherlands
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines
  • Minimal one documented AF episode in the last 6 months
  • Refractory to minimal two Class I or III anti-arrhythmic drug
  • Age > 18 years
  • Signed and dated the Patient Informed Consent.
  • Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin)

Exclusion Criteria:

  • Patient has a structural heart disease
  • Ejection fraction < 40 %
  • Echocardiographic evidence for a left atrium > 45 mm (parasternal axis)
  • Patients on amiodarone, or patients known to be intolerant for amiodarone
  • Dextrocardia, current endocarditis, systemic infection, renal failure
  • Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA
  • Pregnancy at enrolment; or planned pregnancy within the follow up period
  • Patient has a life expectancy less than 1 year
  • The subject is participating in another device or drug study
  • The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
  • Echocardiographic (TTE) evidence for presence of left atrial thrombus
  • Previous (cardio-) thoracic surgery
  • Previous left atrial ablation
  • Patients with permanent or persistent AF

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Arm 1: Catheter Ablation
Procedure: Catheter Ablation
Patients undergoing left atrial circumferential pulmonary vein ostia ablation.
ACTIVE_COMPARATOR: 2
Arm 2: Surgical Ablation.
Procedure: Surgical Ablation
patients undergoing left atrial circumferential pulmonary vein ostia ablation via minimal invasive surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.
Time Frame: Baseline through 3-6 months post-ablation
AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.
Baseline through 3-6 months post-ablation

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment Failures Requiring Redo or Alternative Therapy
Time Frame: Time from procedure until 6 months post-ablation
Time from procedure until 6 months post-ablation
Number of Subjects With Adverse Events, Associated With the Ablation Procedure
Time Frame: Time from procedure
Time from procedure
Mortality and Hospitalization
Time Frame: Time from procedure until 24 months post-ablation
Time from procedure until 24 months post-ablation
Duration, Burden and Costs of Treatment Procedures
Time Frame: Through 24 months post- ablation
Through 24 months post- ablation
Reduced Number, Duration and Severity of AF Symptoms
Time Frame: Through 24 months post-ablation
Through 24 months post-ablation
Symptoms Associated With Atrial Arrhythmias
Time Frame: Through 24 months post-ablation
Through 24 months post-ablation
Occurences of Treatment of Arrhythmic Episodes
Time Frame: Through 24 months post-ablation
Through 24 months post-ablation
Assessment of AF Burden
Time Frame: Through 24 months post-ablation
Through 24 months post-ablation
Reduced Anti-arrhythmic Drug Requirement
Time Frame: Through 24 months post-ablation
Through 24 months post-ablation
Left Atrial Dimension and Contractility
Time Frame: Through 24 months post-ablation
Through 24 months post-ablation

Collaborators and Investigators

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

Sponsor

Medtronic Bakken Research Center

Investigators

  • Principal Investigator: Hauw Sie, MD, Isala

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

November 1, 2007

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (ESTIMATE)

June 23, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC-CS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan or intention to share individual participant data (IPD)

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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