Atrial FibrillationPhase 4NCT01113294
Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation
A Phase 4 study testing catheter ablation in people with Atrial Fibrillation, run by Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,040 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atrial fibrillation recorded by ECG or Holter;
- Age: 18 ~ 75 years;
- Patients who are willing to enroll in the trial
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Cong-xin Huang, doctor, 13907131546, huangcongxin@yahoo.com.cn
Cong-xin Huang, doctor
About this study
Official title: Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial
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.
- Conditions
- Atrial Fibrillation
- Being tested
- catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| ablation | Experimental | Not described Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial arrhythmias (AF, AFL, AT)
Measured: 1 month
recurrence of atrial arrhythmias (AF, AFL, AT)
Measured: 3 month
recurrence of atrial arrhythmias (AF, AFL, AT)
Measured: 6 month
recurrence of atrial arrhythmias (AF, AFL, AT)
Measured: 12 month
Secondary outcomes (16)
Number of participants with all-cause death
Measured: 1 month
Number of participants with all-cause death
Measured: 3 month
Number of participants with all-cause death
Measured: 6 month
Number of participants with all-cause death
Measured: 12 month
severe blooding complications
Measured: 1 month
severe blooding complications
Measured: 3 month
severe blooding complications
Measured: 6 month
severe blooding complications
Measured: 12 month
cardio-cerebrovascular complications
Measured: 1 month
cardio-cerebrovascular complications
Measured: 3 month
cardio-cerebrovascular complications
Measured: 6 month
cardio-cerebrovascular complications
Measured: 12 month
Number of participants with cardiovascular death events
Measured: 1 month
Number of participants with cardiovascular death events
Measured: 3 month
Number of participants with cardiovascular death events
Measured: 6 month
Number of participants with cardiovascular death events
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Cong-xin Huang, doctor, Study chair, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113294
- Sponsor's protocol ID
- AFCT001
- Status last verified
- Jan 2009
- First submitted
- 21 Apr 2010
- Last updated
- 29 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01113294
- Acronym / sponsor ID
- AFCT001
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,040 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- 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
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ablation | Experimental | Procedure: catheter ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Atrial fibrillation recorded by ECG or Holter;
- Age: 18 ~ 75 years;
- Patients who are willing to enroll in the trial
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter ablationcircumferential 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 | Procedure or surgery | ablation |
Primary outcome
recurrence of atrial arrhythmias (AF, AFL, AT)
Time frame: 1 month
recurrence of atrial arrhythmias (AF, AFL, AT)
Time frame: 3 month
recurrence of atrial arrhythmias (AF, AFL, AT)
Time frame: 6 month
recurrence of atrial arrhythmias (AF, AFL, AT)
Time frame: 12 month
16 secondary outcomes
Number of participants with all-cause death
Time frame: 1 month
Number of participants with all-cause death
Time frame: 3 month
Number of participants with all-cause death
Time frame: 6 month
Number of participants with all-cause death
Time frame: 12 month
severe blooding complications
Time frame: 1 month
severe blooding complications
Time frame: 3 month
severe blooding complications
Time frame: 6 month
severe blooding complications
Time frame: 12 month
cardio-cerebrovascular complications
Time frame: 1 month
cardio-cerebrovascular complications
Time frame: 3 month
cardio-cerebrovascular complications
Time frame: 6 month
cardio-cerebrovascular complications
Time frame: 12 month
Number of participants with cardiovascular death events
Time frame: 1 month
Number of participants with cardiovascular death events
Time frame: 3 month
Number of participants with cardiovascular death events
Time frame: 6 month
Number of participants with cardiovascular death events
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2010.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cong-xin Huang, doctor study chair
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing catheter ablation in people with Atrial Fibrillation, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cong-xin Huang, doctor (13907131546, huangcongxin@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of atrial arrhythmias (AF, AFL, AT) (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2010.