Atrial FibrillationNCT01878981
Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
An observational study of Atrial Fibrillation, run by Johnson & Johnson Medical, China.
Trial summary
To generate real world evidence to compare clinical outcomes and patient health-related quality of life, resulting from catheter ablation therapy with clinical outcome and patient health-related quality of life resulting from drug therapy in China. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2011to 23 Nov 2013
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A minimum of 300 subjects in the catheter ablation arm (150 paroxysmal AF patients and 150 persistent AF patients) and 150 subjects in the drug treatment arm (75 paroxysmal AF patients and 75 persistent AF patients).
Who may be able to join
- Patients with paroxysmal or persistent AF eligible for catheter ablation
- Age 18 to 80 years
- Able and willing to comply with all pre,post and follow-up testing and requirements.
- Be able to sign IRB/EC approved informed consent form.
Who cannot join
- Terminal illness with a life expectancy less than 1 year.
- New York Heart Association (NYHA) Class III or IV
- Previous recipient of catheter ablation therapy for AF
- Bradycardia and previous recipient of pacemaker therapy
- Previous recipient RFCA or ICD therapy
- Uncontrolled hypertension
Show all 10Show fewer
- Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
- Patients with serious hepatic and renal diseases
- Pregnant or prepare to be pregnant in one year
- For drug therapy arm, if the subject cannot be contacted via phone or the subject shows his/her disagreement to this study at 30 day window, the subject will be withdrawn from this study.
About this study
To generate real world evidence to compare clinical outcomes and patient health-related quality of life, resulting from catheter ablation therapy with clinical outcome and patient health-related quality of life resulting from drug therapy in China. An economic model will be constructed, and using the clinical events evidence collected in this study, and China long-term disease progression and local disease cost data to perform a cost-effectiveness evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF) patients.
Read the detailed description
The evidence generated by this study is expected to help inform medical decision makers with the clinical and economic data of therapy for AF patients, and also provide policy decision makers with information that can be considered /used to allocate funds for AF ablation and permit patients to have access to appropriate treatment options for AF management.
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter Ablation versus Drug Therapy in AF in China
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of recurrence
the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia
Measured: 9 months followup after baseline
Secondary outcomes (5)
Rate
Total mortality
Measured: 9 month follow up after baseline
total cost
Average total costs of ablation vs. drug therapy per patient
Measured: 9 months follow up
Rate
Stroke
Measured: 9 months follow up from baseline
Rate
Cardiovascular death/Arrhythmic death or Cardiac arrest/Heart failure death
Measured: 9 months from baseline
Duration
Cardiovascular or Cerebrovascular hospitalization
Measured: 9 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study start30 Jun 2011
- Primary completion23 Nov 2013
- Study completion23 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, doctor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878981
- Sponsor's protocol ID
- CAAF 2011
- Status last verified
- Nov 2019
- First submitted
- 29 May 2013
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Du X, Guo L, He X, Jia Y, Wu J, Long D, Yu R, Sang C, Liu X, Yin H, Xuan J, Dong J, Ma C. A comparison of the real world effectiveness of catheter ablation and drug therapy in atrial fibrillation patients in a Chinese setting. BMC Cardiovasc Disord. 2017 Jul 27;17(1):204. doi: 10.1186/s12872-017-0634-y.
PubMed 28750608
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
- ClinicalTrials.gov ID
- NCT01878981
- Acronym / sponsor ID
- CAAF 2011
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter Ablation versus Drug Therapy in AF in China
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 23 Nov 2013 (actual)
- Study completion
- 23 Nov 2013 (actual)
- First posted
- 17 Jun 2013 (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 generate real world evidence to compare clinical outcomes and patient health-related quality of life, resulting from catheter ablation therapy with clinical outcome and patient health-related quality of life resulting from drug therapy in China. An economic model will be constructed, and using the clinical events evidence collected in this study, and China long-term disease progression and local disease cost data to perform a cost-effectiveness evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF) patients.
Detailed description
The evidence generated by this study is expected to help inform medical decision makers with the clinical and economic data of therapy for AF patients, and also provide policy decision makers with information that can be considered /used to allocate funds for AF ablation and permit patients to have access to appropriate treatment options for AF management.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 300 subjects in the catheter ablation arm (150 paroxysmal AF patients and 150 persistent AF patients) and 150 subjects in the drug treatment arm (75 paroxysmal AF patients and 75 persistent AF patients).
Key inclusion criteria (4 listed)
- Patients with paroxysmal or persistent AF eligible for catheter ablation
- Age 18 to 80 years
- Able and willing to comply with all pre,post and follow-up testing and requirements.
- Be able to sign IRB/EC approved informed consent form.
Key exclusion criteria (10 listed)
- Terminal illness with a life expectancy less than 1 year.
- New York Heart Association (NYHA) Class III or IV
- Previous recipient of catheter ablation therapy for AF
- Bradycardia and previous recipient of pacemaker therapy
- Previous recipient RFCA or ICD therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the frequency of recurrence
Time frame: 9 months followup after baseline
the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia
5 secondary outcomes
Rate
Time frame: 9 month follow up after baseline
total cost
Time frame: 9 months follow up
Rate
Time frame: 9 months follow up from baseline
Rate
Time frame: 9 months from baseline
Duration
Time frame: 9 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Derived from this study: PubMed 28750608Du X, Guo L, He X, Jia Y, Wu J, Long D, Yu R, Sang C, Liu X, Yin H, Xuan J, Dong J, Ma C. A comparison of the real world effectiveness of catheter ablation and drug therapy in atrial fibrillation patients in a Chinese setting. BMC Cardiovasc Disord. 2017 Jul 27;17(1):204. doi: 10.1186/s12872-017-0634-y.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Changsheng Ma, doctor principal investigator
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Johnson & Johnson Medical, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of recurrence (time frame: 9 months followup after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878981, which also lists 1 linked publication.
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 14 Nov 2019.