Status:
COMPLETED
Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
Lead Sponsor:
Johnson & Johnson Medical, China
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Brief 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 quali...
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 inf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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be contacted via phone or the subject shows his/her disagreement to this study at 30 day window, the subject will be withdrawn from this study.
Key Trial Info
Start Date :
June 30 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 23 2013
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01878981
Start Date
June 30 2011
End Date
November 23 2013
Last Update
November 14 2019
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