NCT02389218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2020

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

5.2 years

First QC Date

March 9, 2015

Last Update Submit

July 27, 2023

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcryoablationcatheter ablation

Outcome Measures

Primary Outcomes (1)

  • Sinus rhythm

    Sinus rhythm at one year

    one year

Secondary Outcomes (8)

  • Reduction LA volume

    one year

  • Number of cardioversions

    one year

  • Percentage on anti arrhythmic drugs (AAD)

    6 months

  • Percentage on AAD

    12 months

  • Vascular complications

    one year

  • +3 more secondary outcomes

Study Arms (2)

Cryoablation

EXPERIMENTAL

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)

Drug

ACTIVE COMPARATOR

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)

Interventions

single ablation (CryoBalloonAblation (CBA)DEVICE

Cryoablation at entry, after randomization to this group

Cryoablation
sequential drug adjustment (propafenone, sotalol or flecainide)DRUG

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

Drug

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brussels Heart Centre

Brussels, 1000, Belgium

Location

Saint Luc

Brussels, Belgium

Location

Dept Cardiologie

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 18955409BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

PropafenoneSotalolFlecainide

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luc Jordaens, MD, PhD

    Professor of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 17, 2015

Study Start

March 3, 2015

Primary Completion

May 14, 2020

Study Completion

May 14, 2020

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

BE(3)