NCT02292030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 9, 2014

Last Update Submit

November 12, 2014

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • recurrence of atrial fibrillation

    1 year

Study Arms (2)

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

HTEADRUG

usually high thoracic epidural anesthesia

Also known as: High thoracic epidural anesthesia
cardioversion+HTEAonly cardioversion

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

congestive heart failure.

You may qualify if:

  • congestive heart failure accompanied by atrial fibrillation.

You may not qualify if:

  • Valvular heart diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ren Xiaohui

Harbin, Heilongjiang, 150001, China

RECRUITING

the first affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 9, 2014

First Posted

November 17, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

CN(2)