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

NCT01878981 | Completed

• 1 other identifier: CAAF 2011
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

Catheter Ablation versus Drug Therapy in AF in China

Outcome Measures

Primary Outcomes (1)

• the frequency of recurrence

  the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia

  9 months followup after baseline

Secondary Outcomes (5)

• Rate

  9 month follow up after baseline

• total cost

  9 months follow up

• Rate

  9 months follow up from baseline

• Rate

  9 months from baseline

• Duration

  9 months from baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Medical, China: lead

Related Publications (1)

• 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.

  PMID: 28750608 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Changsheng Ma, doctor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 17, 2013
• Study Start: June 30, 2011
• Primary Completion: November 23, 2013
• Study Completion: November 23, 2013
• Last Updated: November 14, 2019

Record last verified: 2019-11