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OpenTrials
Completed

NCT Number: NCT01878981

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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be contacted via phone or the subject shows his/her disagreement to this study at 30 day window, the subject will be withdrawn from this study.

Treatment and study plan

Primary outcomes

  1. the frequency of recurrence

    Time frame: 9 months followup after baseline

    the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia

Secondary outcomes

  1. Rate

    Time frame: 9 month follow up after baseline

    Total mortality

  2. total cost

    Time frame: 9 months follow up

    Average total costs of ablation vs. drug therapy per patient

  3. Rate

    Time frame: 9 months follow up from baseline

    Stroke

  4. Rate

    Time frame: 9 months from baseline

    Cardiovascular death/Arrhythmic death or Cardiac arrest/Heart failure death

  5. Duration

    Time frame: 9 months from baseline

    Cardiovascular or Cerebrovascular hospitalization

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Medical, China

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2013
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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