NCT02732626

Brief Summary

This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation lines in addition to pulmonary vein isolation may improve the outcome in patients with persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
3 countries

6 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

First Submitted

Initial submission to the registry

March 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

4.7 years

First QC Date

March 23, 2016

Last Update Submit

March 10, 2022

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • recurrence of atrial arrhythmia

    recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking

    12 months

Secondary Outcomes (2)

  • Secondary Efficacy Endpoint

    12 months

  • Secondary Safety Endpoint

    90 days

Study Arms (2)

pulmonary vein isolation alone

ACTIVE COMPARATOR

patients randomized to this group receive stand alone pulmonary vein isolation regardless to their left atrial voltage map

Procedure: radiofrequency ablation

pulmonary vein isolation + low voltage area guided ablation

EXPERIMENTAL

patients randomized to this group receive pulmonary vein isolation + low voltage area guided linear substrate modification in the case if there are any

Procedure: radiofrequency ablation

Interventions

radiofrequency ablationPROCEDURE
pulmonary vein isolation + low voltage area guided ablationpulmonary vein isolation alone

Eligibility Criteria

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

You may qualify if:

  • Symptomatic patients with persistent AF documented by 12 lead ECGs (Persistent AF is defined as an AF episode which lasts longer than 7 days, Persistent AF which lasted longer than 12 months will be defined as long standing persistent AF.)
  • Age 18 - 80 years, both genders
  • Patient is willing to participate in the study (signed written informed consent)
  • Patient is willing and available to perform all follow ups.

You may not qualify if:

  • Atrial fibrillation due to reversible causes
  • Any contraindication for AF ablation
  • Contraindications to anticoagulation
  • CVA/TIA in the past 6 months
  • Previous left atrial catheter ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Moedling Hospital

Mödling, Lower Austria, 2340, Austria

Location

Elisabethinen Hospital

Linz, Upper Austria, 4020, Austria

Location

Landesklinikum Wiener Neustadt

Vienna, Austria

Location

Heart Center Dresden

Dresden, Saxony, 01307, Germany

Location

Sana Kliniken Lübeck

Lübeck, Germany

Location

Medical University of Lublin

Lublin, Poland

Location

Related Publications (1)

  • Huo Y, Gaspar T, Schonbauer R, Wojcik M, Fiedler L, Roithinger FX, Martinek M, Purerfellner H, Kirstein B, Richter U, Ulbrich S, Mayer J, Krahnefeld O, Agdirlioglu T, Zedda A, Piorkowski J, Piorkowski C. Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation. NEJM Evid. 2022 Nov;1(11):EVIDoa2200141. doi: 10.1056/EVIDoa2200141. Epub 2022 Oct 19.

    PMID: 38319851DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Christopher Piorkowski, MD

    Heart Center Dresden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 8, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

DE(2)AU(3)PL(1)