Catheter Ablation and Rate Control of Atrial Fibrillation... | NCT02846922

Studies
Catheter Ablation and Rate Control of Atrial Fibrillation in Patients With Heart Failure

NCT02846922

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

394Actual

Phase

Not provided

Conditions

Catheter Ablation
Rate Control
Heart Failure
Atrial Fibrillation

Interventions

Not provided

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

Jul 2023

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

Aug 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 25, 2016

First Submission Date that Met QC Criteria

Jul 25, 2016

First Posted Date

Jul 27, 2016Estimated

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

Jul 11, 2023

Last Update Posted Date

Jul 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.

Detailed Description

All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

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

394Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
catheter ablation group		atrial fibrillation patients with heart failure who received catheter ablation for rhythm control
rate control group		atrial fibrillation patients with heart failure who received pharmacological approaches for rate control

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse cardiac events	composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons	up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
all-cause mortality		up to 3 years
stroke	stroke must be certified by CT scan	up to 3 years
unplanned hospitalization due to cardiovascular reasons

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age>18 years
documented atrial fibrillation
New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction <50%

Exclusion Criteria:

heart failure that had a suspected reversible cause
previous ablation
any contraindication to catheter ablation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients coexisted with heart failure and atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Geng, MD	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Principal Investigator
Bingjian Wang, MD	Huai'an First People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Drum Tower Hospital		Nanjing	Jiangsu	210008	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001281	Atrial Fibrillation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided