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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01878981
• Lead Sponsor: Johnson & Johnson Medical, China

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.

Study Timeline

• Study Start: 2011-06-30
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Primary Completion: 2013-11-23
• Study Completion: 2013-11-23
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the frequency of recurrence	9 months followup after baseline	the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia

Secondary Outcome Measures

Name	Time	Method
Rate	9 months from baseline	Cardiovascular death/Arrhythmic death or Cardiac arrest/Heart failure death
total cost	9 months follow up	Average total costs of ablation vs. drug therapy per patient
Duration	9 months from baseline	Cardiovascular or Cerebrovascular hospitalization