Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China

Atrial Fibrillation Clinical Trial

Official title:

Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878981
• Other study ID #: CAAF 2011
• Status: Completed
• Start date: June 30, 2011
• Est. completion date: November 23, 2013

Study information

• Verified date: November 2019
• Source: Johnson & Johnson Medical, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 23, 2013
• Est. primary completion date: November 23, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Medical, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the frequency of recurrence	the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia	9 months followup after baseline
Secondary	Rate	Total mortality	9 month follow up after baseline
Secondary	total cost	Average total costs of ablation vs. drug therapy per patient	9 months follow up
Secondary	Rate	Stroke	9 months follow up from baseline
Secondary	Rate	Cardiovascular death/Arrhythmic death or Cardiac arrest/Heart failure death	9 months from baseline
Secondary	Duration	Cardiovascular or Cerebrovascular hospitalization	9 months from baseline