Clinical trial NCT01878981: Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
Official title: Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Catheter Ablation versus Drug Therapy in AF in China
Lead sponsor: Johnson & Johnson Medical, China
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the frequency of recurrence
timeFrame: 9 months followup after baseline
Secondary outcomes:
measure: Rate
timeFrame: 9 month follow up after baseline
measure: total cost
timeFrame: 9 months follow up
measure: Rate
timeFrame: 9 months follow up from baseline
measure: Rate
timeFrame: 9 months from baseline
measure: Duration
timeFrame: 9 months from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.