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Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
catheter ablation
Sponsored by
Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Atrial fibrillation recorded by ECG or Holter;
  2. Age: 18 ~ 75 years;
  3. Patients who are willing to enroll in the trial

Exclusion Criteria:

  1. 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

Sites / Locations

  • Renmin Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ablation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with all-cause death
Number of participants with all-cause death
Number of participants with all-cause death
Number of participants with all-cause death
severe blooding complications
severe blooding complications
severe blooding complications
severe blooding complications
cardio-cerebrovascular complications
cardio-cerebrovascular complications
cardio-cerebrovascular complications
cardio-cerebrovascular complications
Number of participants with cardiovascular death events
Number of participants with cardiovascular death events
Number of participants with cardiovascular death events
Number of participants with cardiovascular death events

Full Information

First Posted
April 21, 2010
Last Updated
April 27, 2010
Sponsor
Wuhan University
Collaborators
Peking Union Medical College, Shanghai Chest Hospital, Nanjing Medical University, West China Hospital, Guangdong Provincial People's Hospital, Dalian Medical University, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01113294
Brief Title
Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation
Official Title
Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Wuhan University
Collaborators
Peking Union Medical College, Shanghai Chest Hospital, Nanjing Medical University, West China Hospital, Guangdong Provincial People's Hospital, Dalian Medical University, Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of different procedures, identify the optimal procedure, ablation sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal treatment strategy for atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2040 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ablation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
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
Primary Outcome Measure Information:
Title
recurrence of atrial arrhythmias (AF, AFL, AT)
Time Frame
1 month
Title
recurrence of atrial arrhythmias (AF, AFL, AT)
Time Frame
3 month
Title
recurrence of atrial arrhythmias (AF, AFL, AT)
Time Frame
6 month
Title
recurrence of atrial arrhythmias (AF, AFL, AT)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Number of participants with all-cause death
Time Frame
1 month
Title
Number of participants with all-cause death
Time Frame
3 month
Title
Number of participants with all-cause death
Time Frame
6 month
Title
Number of participants with all-cause death
Time Frame
12 month
Title
severe blooding complications
Time Frame
1 month
Title
severe blooding complications
Time Frame
3 month
Title
severe blooding complications
Time Frame
6 month
Title
severe blooding complications
Time Frame
12 month
Title
cardio-cerebrovascular complications
Time Frame
1 month
Title
cardio-cerebrovascular complications
Time Frame
3 month
Title
cardio-cerebrovascular complications
Time Frame
6 month
Title
cardio-cerebrovascular complications
Time Frame
12 month
Title
Number of participants with cardiovascular death events
Time Frame
1 month
Title
Number of participants with cardiovascular death events
Time Frame
3 month
Title
Number of participants with cardiovascular death events
Time Frame
6 month
Title
Number of participants with cardiovascular death events
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atrial fibrillation recorded by ECG or Holter; Age: 18 ~ 75 years; Patients who are willing to enroll in the trial Exclusion Criteria: Patients accompanied hyperthyroidism; Patients with sever liver or renal dysfunction; Patients with sever cardiac dysfunction; Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure; Patients with emboli in atrium; Pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cong-xin Huang, doctor
Phone
13907131546
Email
huangcongxin@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cong-xin Huang, doctor
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cong-xin Huang, doctor
Phone
13907131546
Email
huangcongxin@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Cong-xin Huang, doctor

12. IPD Sharing Statement

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Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

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