NCT01877473

Brief Summary

The hypothesis of this study is that by facilitating reverse atrial remodeling with maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex atrial ablation for patients with persistent AF.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

May 26, 2013

Last Update Submit

June 16, 2014

Conditions

Persistent Atrial Fibrillation

Keywords

atrial fibrillationpersistent AFcatheter ablationduration of 7 days to one yearwith symptoms and failure of at least one antiarrhythmic drug

Outcome Measures

Primary Outcomes (1)

  • Freedom of atrial fibrillation/flutter

    One year

Study Arms (2)

Reverse remodeling

ACTIVE COMPARATOR

Pretreatment with dofetilide or sotalol and restoration of sinus rhythm followed by PVI only ablation

Procedure: Ablation

Standard ablation

ACTIVE COMPARATOR

PVI ablation with additional CFAE and/or linear LA ablation

Procedure: Ablation

Interventions

AblationPROCEDURE
Reverse remodelingStandard ablation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic persistent AF
  • Failure of class I antiarrhythmic drug or amiodarone to control AF

You may not qualify if:

  • Previous proarrhythmia to class III AAD including excessive QT prolongation or torsade-de-pointes
  • Previous AF ablation procedure
  • Congestive heart failure (NYHA III-IV functional class)
  • Left ventricle ejection fraction less than 35%
  • Left atrial diameter \>55 mm
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan S Steinberg, MD

    Valley Health System/Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Arrhythmia Institute

Study Record Dates

First Submitted

May 26, 2013

First Posted

June 13, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

US(1)