This trial is active, not recruiting.

Condition atrial fibrillation
Sponsor Johnson & Johnson Medical, China
Start date June 2011
End date November 2013
Trial size 450 participants
Trial identifier NCT01878981, CAAF 2011


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

the frequency of recurrence
time frame: 9 months followup after baseline

Secondary Outcomes

time frame: 9 month follow up after baseline
total cost
time frame: 9 months follow up
time frame: 9 months follow up from baseline
time frame: 9 months from baseline
time frame: 9 months from baseline

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - 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 Criteria: - 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be contacted via phone or the subject shows his/her disagreement to this study at 30 day window, the subject will be withdrawn from this study.

Additional Information

Official title Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
Principal investigator Changsheng Ma, doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Johnson & Johnson Medical, China.