Cardioversion of Atrial Fibrillation Accompanied by Chron... | NCT02292030

Studies
Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure

NCT02292030

Sponsor

Harbin Medical University

Status

Unknown status

Last Update Posted

Nov 17, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Chronic Heart Failure

Interventions

HTEA

Countries

China

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Nov 9, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 17, 2014Estimated

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 12, 2014

Last Update Posted Date

Nov 17, 2014Estimated

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

The purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

Detailed Description

The purpose of this study is to explore the efficacy of low energy (30J) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardioversion+HTEA		Heart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion+HTEA.	Drug: HTEA
only cardioversion		Heart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion, but not with HTEA.	Drug: HTEA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HTEA	Drug	usually high thoracic epidural anesthesia	cardioversion+HTEA only cardioversion

Measure	Description	Time Frame
recurrence of atrial fibrillation		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

congestive heart failure accompanied by atrial fibrillation.

Exclusion Criteria:

Valvular heart diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

congestive heart failure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ren Xiaohui	Recruiting	Harbin	Heilongjiang	150001	China