NCT02059369

Brief Summary

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

May 23, 2013

Last Update Submit

April 10, 2017

Conditions

Atrial FibrillationRecurrence

Keywords

Atrial fibrillationRecurrenceCFAElinear ablation

Outcome Measures

Primary Outcomes (1)

  • Freedom from atrial arrhythmia

    Documented freedom from atrial arrhythmia (AF or AT) recurrence

    12 months

Secondary Outcomes (2)

  • Procedural and safety data

    12 months

  • Number and result of reablation procedure

    12 months

Study Arms (2)

CFAE ablation

ACTIVE COMPARATOR

Intervention: Complex fractionated atrial electrograms (CFAE) Ablation

Procedure: PVI+CFAE+DCC

CFAE + Lines

ACTIVE COMPARATOR

CFAE Ablation followed by linear lesions (anterior and Roof line)

Procedure: PVI, CFAE, anterior and roof line, DCC

Interventions

PVI+CFAE+DCCPROCEDURE

pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists

CFAE ablation
PVI, CFAE, anterior and roof line, DCCPROCEDURE

PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists

CFAE + Lines

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic persistent AF
  • After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia

You may not qualify if:

  • Left atrial thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

Munich, 80636, Germany

Location

MeSH Terms

Conditions

Atrial FibrillationRecurrence

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

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

May 23, 2013

First Posted

February 11, 2014

Study Start

August 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

DE(1)