NCT01341353

Brief Summary

The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter ablation has increasingly been used over the last decades. The relative merits of each strategy have not been extensively studied. Our study was designed to determine if catheter ablation is a feasible option as first-line therapy for treating patients with symptomatic AF.

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
1,800

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Apr 2011

Typical duration for phase_4 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

April 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

Enrollment Period

3.7 years

First QC Date

April 21, 2011

Last Update Submit

April 21, 2011

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (16)

  • Number of participants with all-cause death

    3 month

  • Number of participants with all-cause death

    12 month

  • Number of participants with all-cause death

    24 month

  • Number of participants with all-cause death

    36 month

  • severe blooding complications

    3 month

  • severe blooding complications

    12 month

  • severe blooding complications

    24 month

  • severe blooding complications

    36 month

  • cardio-cerebrovascular complications

    3 month

  • cardio-cerebrovascular complications

    12 month

  • cardio-cerebrovascular complications

    24 month

  • cardio-cerebrovascular complications

    36 month

  • Number of participants with cardiovascular death events

    3 month

  • Number of participants with cardiovascular death events

    12 month

  • Number of participants with cardiovascular death events

    24 month

  • Number of participants with cardiovascular death events

    36 month

Secondary Outcomes (7)

  • recurrence of atrial arrhythmias (AF, AFL, AT)

    3 month

  • recurrence of atrial arrhythmias (AF, AFL, AT)

    12 month

  • recurrence of atrial arrhythmias (AF, AFL, AT)

    24 month

  • recurrence of atrial arrhythmias (AF, AFL, AT)

    36 month

  • resource utilization and costs

    12 month

  • +2 more secondary outcomes

Study Arms (2)

Antiarrythmic Drugs

ACTIVE COMPARATOR
Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists

ablation

EXPERIMENTAL
Procedure: catheter ablation

Interventions

catheter ablationPROCEDURE

circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation

ablation
Digaoxin,amiodarone,β receptor antagonist, Calcium AntagonistsDRUG
Antiarrythmic Drugs

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic AF recorded by ECG or Holter 2 Age:18-75 years 3 Patients who are willing to enroll in the trial

You may not qualify if:

  • Patients accompanied hyperthyroidism 2 Patients with sever liver or renal dysfunction 3 Patients with sever cardiac dysfunction 4 Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure 5 Patients with emboli in atrium 6 Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter AblationCalcium Channel Blockers

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic Uses

Study Officials

  • Cong xin Huang, doctor

    Renmin Hospital of Wuhan University

    STUDY CHAIR

Central Study Contacts

Cong xin Huang, doctor

CONTACT

13907131546huangcongxin@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 25, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

April 25, 2011

Record last verified: 2011-04

Locations

CN(1)