Health Economics Evaluation of Catheter Ablation Versus D... | NCT01878981

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

NCT01878981

Sponsor

Johnson & Johnson Medical, China

Status

Completed

Last Update Posted

Nov 14, 2019Actual

Enrollment

450Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2011Actual

Primary Completion Date

Nov 23, 2013Actual

Completion Date

Nov 23, 2013Actual

First Submitted Date

May 29, 2013

First Submission Date that Met QC Criteria

Jun 13, 2013

First Posted Date

Jun 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2019

Last Update Posted Date

Nov 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Rate	Total mortality	9 month follow up after baseline
total cost	Average total costs of ablation vs. drug therapy per patient	9 months follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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).

Sampling Method

Probability Sample

Name	Affiliation	Role
Changsheng Ma, doctor	Beijing Anzhen Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28750608	Derived	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.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes