NCT02696265

Brief Summary

Objective: The purpose of this study is to compare the efficacy and safety of ablation of Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based ablation in patients with persistent AF. Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival compared to a PVI guided ablation. Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into one of two study arms:

  • CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation.
  • PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

October 12, 2016

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

8.7 years

First QC Date

February 18, 2016

Last Update Submit

July 11, 2022

Conditions

Chronic Atrial Fibrillation

Keywords

Atrial FibrillationComplex Fractionated Atrial ElectrocardiogramsPulmonary Vein IsolationAblationCFAE/spatiotemporal dispersion guided ablation

Outcome Measures

Primary Outcomes (1)

  • Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia (>30 seconds) recurrences without the use of class I or III AADs

    Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (\>30 seconds) without the use of class I or III AADs through 18 months follow-up, post blanking period after ablation on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring

    18 months

Secondary Outcomes (16)

  • Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds) regardless of antiarrhythmic drugs

    18 months

  • Freedom from recorded atrial fibrillation or atrial flutter recurrences (>30 seconds) regardless of antiarrhythmic drugs

    18 months

  • Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds), without a new AAD or a previously failed AAD at a greater than the highest ineffective historical dose

    18 months

  • Freedom from recorded atrial fibrillation (>30 seconds), regardless of antiarrhythmic drugs

    18 months

  • Clinical/partial success at 18 months regardless of antiarrhythmic drug use

    18 months

  • +11 more secondary outcomes

Study Arms (2)

CFAE guided ablation

ACTIVE COMPARATOR

CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation.

Procedure: CFAE guided ablation

PVI guided ablation

ACTIVE COMPARATOR

PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals.

Procedure: PVI guided ablation

Interventions

CFAE guided ablationPROCEDURE

CFAE/spatiotemporal dispersions mapping and ablation during AF aimed at restoring sinus rhythm during ablation. Pulmonal vein isolation will be checked before and after ablation using a mapping catheter.

CFAE guided ablation
PVI guided ablationPROCEDURE

Wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals

PVI guided ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
  • Sustained beyond 7 days but no more than one year.
  • Or lasting less than 7 days, but longer than 48 hours and necessitating pharmacologic or electrical cardioversion.
  • Documentation of atrial fibrillation on either a 12-lead ECG or transtelephonic monitoring (TTM), or ambulatory holter monitoring or telemetry strip and a physician's note showing continuous AF.
  • Failure of at least one AAD (Class I or III) as evidenced by recurrent symptomatic AF or intolerable side effects of the AAD.
  • Signed Patient Informed Consent Form.
  • Age 18 years or older.
  • Able and willing to comply with all pre- and follow-up testing and requirements.

You may not qualify if:

  • \. Continuous AF \> 12 months (1-Year) (Longstanding Persistent AF).
  • Previous surgical or catheter ablation for atrial fibrillation.
  • Any cardiac surgery within the past 2 months (60 days) (includes PCI).
  • CABG surgery within the past 6 months (180 days).
  • Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
  • Cardioversion refractory (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion).
  • If a patient does not have documented evidence of being successfully cardioverted (NSR \> 30 secs), the patient must be cardioverted prior to the ablation procedure with the study catheter.
  • Failure to cardiovert based on the above criteria is considered a screen failure.
  • Documented LA thrombus on imaging.
  • LA size \>50 mm.
  • LVEF \< 30%.
  • Contraindication to anticoagulation (heparin or warfarin).
  • History of blood clotting or bleeding abnormalities.
  • Myocardial infarction within the past 2 months (60 days).
  • Documented thromboembolic event (including TIA) within the past 12 months (365 days).
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Saint Joseph

Marseille, France

RECRUITING

CHU de Nice

Nice, France

NOT YET RECRUITING

Kagoshima University

Kagoshima, Japan

RECRUITING

Isala

Zwolle, Overijssel, 8025 AB, Netherlands

RECRUITING

Related Publications (1)

  • Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

    PMID: 28104073BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jaap-Jan J. Smit, MD, PhD

    Isala

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gery de Jong, PhD

CONTACT

++31(0)38-4262999CIPA@diagram-zwolle.nl

Ilona C. Kalter, Msc

CONTACT

++31(0)38-4262999CIPA@diagram-zwolle.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 2, 2016

Study Start

October 12, 2016

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)FR(2)JP(1)