NCT04442113

Brief Summary

Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity. Catheter ablation is a safe treatment which is effective for paroxysmal AF but the success rate for persistent AF remains approximately 50% at 1 year. A new mapping technique, called Stochastic Trajectory Analysis of Ranked signals (STAR Mapping™) Method, has recently been developed. In a pilot study, localised sources driving AF were consistently mapped and ablated with excellent acute and long term outcomes. This trial will test the clinical effectiveness of this approach by comparing conventional ablation with pulmonary vein isolation (PVI) to PVI plus STAR mapping™ guided ablation. We plan to test this through a prospective multicenter randomized controlled trial including 177 patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable atrial-fibrillation

Status
withdrawn

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

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

June 18, 2020

Last Update Submit

April 9, 2021

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCatheter ablationArrhythmiaCardiac mapping

Outcome Measures

Primary Outcomes (2)

  • Comparison of the proportion of subjects in the 2 groups with clinical success

    Clinical success is defined as freedom from atrial arrhythmia (AF or atrial tachycardia) lasting \>30 seconds after a single procedure off antiarrhythmic drugs subsequent to a 3 month blanking period (standard guideline definition of clinical success).

    12 months

  • Comparison of the proportion of subjects in the 2 groups with termination of AF during ablation

    Termination of AF during ablation

    During the index procedure (i.e. day 0)

Secondary Outcomes (9)

  • Comparison of the proportion of subjects in the 2 groups with major complications following their index procedure.

    30 days

  • Comparison of the proportion of subjects in the 2 groups with early failure following their index procedure.

    3 months

  • Comparison of the proportion of subjects in the 2 groups reaching a composite electrophysiological end point during their index procedure

    During the index ablation procedure (i.e. day 0)

  • Radiofrequency ablation time

    Intraprocedural

  • Procedure time

    Intraprocedural

  • +4 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Pulmonary vein isolation alone (by catheter ablation)

Procedure: Pulmonary vein isolation

STAR guided ablation group

EXPERIMENTAL

Pulmonary vein isolation plus ablation guided by STAR MappingTM

Procedure: Pulmonary vein isolation plus ablation guided by novel STAR mapping™

Interventions

Pulmonary vein isolation plus ablation guided by novel STAR mapping™PROCEDURE

Catheter ablation for persistent AF consisting of pulmonary vein isolation plus additional ablation guided by the novel STAR mapping™ software on a computer device.

STAR guided ablation group
Pulmonary vein isolationPROCEDURE

Catheter ablation for persistent AF consisting of pulmonary vein isolation (the standard treatment for AF)

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent AF (continuous AF duration between 1 week and 24 months)
  • No previous AF ablation or other left atrial ablation
  • Undergoing a clinical AF ablation procedure.

You may not qualify if:

  • Unwillingness to sign consent
  • Any other contraindication to catheter ablation
  • Age \<18 years or \> 80 years
  • AF with a reversible cause
  • AF that is paroxysmal
  • AF that has been persistent \> 2 yrs
  • Previous left atrial ablation (percutaneous or surgical)
  • Severe LV impairment (EF \< 40%)
  • NYHA class 3 or 4 heart failure
  • Severely dilated left atrium (LA diameter \> 50 mm)
  • Known cardiomyopathy or inherited 'channelopathy'
  • Congential heart disease (excluding PFO)
  • More than moderate valvular heart disease or prosthetic heart valves
  • Prior MI, PCI or cardiac surgery in the last 6 months
  • Pregnancy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Honarbakhsh S, Hunter RJ, Finlay M, Ullah W, Keating E, Tinker A, Schilling RJ. Development, in vitro validation and human application of a novel method to identify arrhythmia mechanisms: The stochastic trajectory analysis of ranked signals mapping method. J Cardiovasc Electrophysiol. 2019 May;30(5):691-701. doi: 10.1111/jce.13882. Epub 2019 Mar 5.

    PMID: 30801836BACKGROUND

  • Honarbakhsh S, Hunter RJ, Ullah W, Keating E, Finlay M, Schilling RJ. Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method. JACC Clin Electrophysiol. 2019 Jul;5(7):817-829. doi: 10.1016/j.jacep.2019.04.007. Epub 2019 May 8.

    PMID: 31320010BACKGROUND

  • Honarbakhsh S, Schilling RJ, Finlay M, Keating E, Ullah W, Hunter RJ. STAR mapping method to identify driving sites in persistent atrial fibrillation: Application through sequential mapping. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2694-2703. doi: 10.1111/jce.14201. Epub 2019 Oct 3.

    PMID: 31552697BACKGROUND

  • Honarbakhsh S, Schilling RJ, Keating E, Finlay M, Hunter RJ. Drivers in AF colocate to sites of electrogram organization and rapidity: Potential synergy between spectral analysis and STAR mapping approaches in prioritizing drivers for ablation. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1340-1349. doi: 10.1111/jce.14456. Epub 2020 Apr 9.

    PMID: 32219906BACKGROUND

Related Links

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

December 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

April 14, 2021

Record last verified: 2021-04