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

November 13, 2019 updated by: Johnson & Johnson Medical, 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the frequency of recurrence
Time Frame: 9 months followup after baseline
the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia
9 months followup after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate
Time Frame: 9 month follow up after baseline
Total mortality
9 month follow up after baseline
total cost
Time Frame: 9 months follow up
Average total costs of ablation vs. drug therapy per patient
9 months follow up
Rate
Time Frame: 9 months follow up from baseline
Stroke
9 months follow up from baseline
Rate
Time Frame: 9 months from baseline
Cardiovascular death/Arrhythmic death or Cardiac arrest/Heart failure death
9 months from baseline
Duration
Time Frame: 9 months from baseline
Cardiovascular or Cerebrovascular hospitalization
9 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Medical, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2011

Primary Completion (Actual)

November 23, 2013

Study Completion (Actual)

November 23, 2013

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAF 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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