A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF (METACSA)

July 27, 2023 updated by: University Hospital, Ghent

A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent Atrial Fibrilation

Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The total AF history should be shorter than 24 months. Symptomatic patients can be included if they have had within the last year at least 2 episodes of documented AF, lasting minimal 30 sec. One episode in the entire history should have lasted more than 48 h, requiring electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.

All patients eligible for the study will sign informed consent, have an echocardiogram prior to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.

Prior to randomization, and after inclusion it is suggested to the local investigators to perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study ) in eligible patients to assess the anatomy and the left atrial volume. The results should not influence the strategy of treatment.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

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

  • Belgium
      • Brussels, Belgium, 1000
        • Brussels Heart Centre
      • Brussels, Belgium
        • Saint Luc
      • Gent, Belgium, 9000
        • Dept Cardiologie

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

19 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • > 21 years and legally capable
  • First documentation or history of symptomatic AF more than 30 sec within the last 2 years
  • Twice AF within the last year
  • One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
  • Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
  • Left ventricular ejection fraction estimated > 45%
  • LA diameter < 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)
  • CHADS2 ≤ 2
  • Failed AAD strategy, or untreated with AAD
  • No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)
  • Informed consent

Exclusion Criteria:

  • Age > 75 yrs
  • CHF
  • Ischemic heart disease as known in the history
  • (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd > 14 mm)
  • Hyperthyroidism
  • Congenital heart disease
  • Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies
  • Contra-indications to AAD
  • Long QT syndrome
  • Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)
  • Pure (typical) atrial flutter as documented on one occasion

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
Experimental: Cryoablation
Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated.
Device: single ablation (CryoBalloonAblation (CBA)
Cryoablation at entry, after randomization to this group
Active Comparator: Drug
Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage
Drug: sequential drug adjustment (propafenone, sotalol or flecainide)
Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus rhythm
Time Frame: one year
Sinus rhythm at one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction LA volume
Time Frame: one year
Reduction left atrial volume in successfully treated patients
one year
Number of cardioversions
Time Frame: one year
Number of cardioversions
one year
Percentage on anti arrhythmic drugs (AAD)
Time Frame: 6 months
Percentage on AAD in each group
6 months
Percentage on AAD
Time Frame: 12 months
Percentage on AAD in each group
12 months
Vascular complications
Time Frame: one year
Vascular complications, including tamponade
one year
Stroke, transient ischemic attack (TIA)
Time Frame: one year
Stroke, TIA (symptomatic)
one year
Serious adverse events (SAE)
Time Frame: one year
Adverse events leading to admission or death
one year
Freedom of AF
Time Frame: one year
Freedom of atrial fibrillation with all means
one year

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Luc Jordaens, MD, PhD, Professor of Cardiology

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)

March 3, 2015

Primary Completion (Actual)

May 14, 2020

Study Completion (Actual)

May 14, 2020

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimated)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1113

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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