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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

single ablation (CryoBalloonAblation (CBA)

sequential drug adjustment (propafenone, sotalol or flecainide)

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, cryoablation, catheter ablation

Eligibility Criteria

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

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

Sites / Locations

Brussels Heart Centre
Saint Luc
Dept Cardiologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryoablation

Drug

Arm Description

Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated.

Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage

Outcomes

Primary Outcome Measures

Sinus rhythm

Sinus rhythm at one year

Secondary Outcome Measures

Reduction LA volume

Reduction left atrial volume in successfully treated patients

Number of cardioversions

Percentage on anti arrhythmic drugs (AAD)

Percentage on AAD in each group

Percentage on AAD

Percentage on AAD in each group

Vascular complications

Vascular complications, including tamponade

Stroke, transient ischemic attack (TIA)

Stroke, TIA (symptomatic)

Serious adverse events (SAE)

Adverse events leading to admission or death

Freedom of AF

Freedom of atrial fibrillation with all means

Full Information

NCT ID

NCT02389218

First Posted

March 9, 2015

Last Updated

July 27, 2023

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT02389218

Brief Title

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

Acronym

METACSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

March 3, 2015 (Actual)

Primary Completion Date

May 14, 2020 (Actual)

Study Completion Date

May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

atrial fibrillation, cryoablation, catheter ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryoablation

Arm Type

Experimental

Arm Description

Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated.

Arm Title

Drug

Arm Type

Active Comparator

Arm Description

Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage

Intervention Type

Device

Intervention Name(s)

single ablation (CryoBalloonAblation (CBA)

Intervention Description

Cryoablation at entry, after randomization to this group

Intervention Type

Drug

Intervention Name(s)

sequential drug adjustment (propafenone, sotalol or flecainide)

Intervention Description

Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone

Primary Outcome Measure Information:

Title

Sinus rhythm

Description

Sinus rhythm at one year

Time Frame

one year

Secondary Outcome Measure Information:

Title

Reduction LA volume

Description

Reduction left atrial volume in successfully treated patients

Time Frame

one year

Title

Number of cardioversions

Description

Number of cardioversions

Time Frame

one year

Title

Percentage on anti arrhythmic drugs (AAD)

Description

Percentage on AAD in each group

Time Frame

6 months

Title

Percentage on AAD

Description

Percentage on AAD in each group

Time Frame

12 months

Title

Vascular complications

Description

Vascular complications, including tamponade

Time Frame

one year

Title

Stroke, transient ischemic attack (TIA)

Description

Stroke, TIA (symptomatic)

Time Frame

one year

Title

Serious adverse events (SAE)

Description

Adverse events leading to admission or death

Time Frame

one year

Title

Freedom of AF

Description

Freedom of atrial fibrillation with all means

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luc Jordaens, MD, PhD

Organizational Affiliation

Professor of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brussels Heart Centre

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Saint Luc

City

Brussels

Country

Belgium

Facility Name

Dept Cardiologie

City

Gent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

18955409

Citation

Van Belle Y, Janse P, Theuns D, Szili-Torok T, Jordaens L. One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation. Europace. 2008 Nov;10(11):1271-6. doi: 10.1093/europace/eun218.

Results Reference

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

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