NCT01716143

Brief Summary

The purpose of this study is to determine whether left atrium substrate based ablation plus circumferential is effective in the treatment of persistent and long-standing atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

2.3 years

First QC Date

October 23, 2012

Last Update Submit

October 25, 2012

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablationMapping

Outcome Measures

Primary Outcomes (1)

  • The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 3,6,12,18 and 24 months after a single-ablation. procedure.

    3 years

Secondary Outcomes (1)

  • The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation

    December 31, 2012

Study Arms (1)

catheter ablation

OTHER
Procedure: radiofrequency catheter ablation

Interventions

radiofrequency catheter ablationPROCEDURE
catheter ablation

Eligibility Criteria

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

You may qualify if:

  • All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.

You may not qualify if:

  • Patients with paroxysmal AF (self-terminating episodes lasting \< 7 day)
  • Patients who have had a previous AF ablation procedure
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

  • Yang G, Yang B, Wei Y, Zhang F, Ju W, Chen H, Li M, Gu K, Lin Y, Wang B, Cao K, Kojodjojo P, Chen M. Catheter Ablation of Nonparoxysmal Atrial Fibrillation Using Electrophysiologically Guided Substrate Modification During Sinus Rhythm After Pulmonary Vein Isolation. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e003382. doi: 10.1161/CIRCEP.115.003382.

    PMID: 26857907DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Minglong Chen, MD

CONTACT

0086-25-6813-6965chenminglong@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 29, 2012

Study Start

March 1, 2010

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

CN(1)