Association Between S-LAAO and Adverse Cardiovascular Eve... | NCT04108169

Studies
Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.

NCT04108169

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status

Unknown status

Last Update Posted

Sep 30, 2019Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Heart Surgery

Interventions

Left atrial appendage occlusion surgery

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

Sep 2019

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

Oct 1, 2019Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Sep 26, 2019

First Submission Date that Met QC Criteria

Sep 27, 2019

First Posted Date

Sep 30, 2019Actual

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

Sep 27, 2019

Last Update Posted Date

Sep 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Comparator	Active Comparator		Procedure: Left atrial appendage occlusion surgery
Sham Comparator	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Left atrial appendage occlusion surgery	Procedure	CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause death		3 year after discharge (These data is collected during follow-up visit at in-hospital)

Secondary Outcomes

Measure	Description	Time Frame
Atrial fibrillation		3 year after discharge (These data is collected during follow-up visit at in-hospital)
Composite of ischemic stroke, thromboembolism and all death		3 year after discharge (These data is collected during follow-up visit at in-hospital)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject undergoing coronary artery bypass grafting according to clinical indications;
Age is more than 18 and less than 80 years old;
Male and non pregnancy female;
Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria:

Pregnancy female;
Participate in other clinical trial in the last 1 month.
Subject doesn't agree to sign an informed consent from prior to study procedures.
Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
New York Heart Association (NYHA) Class IV heart failure.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yulin Li, PHD	Contact	86-010-64426153		lyllyl_1111@163.com
Ping Li, PHD	Contact			13520112185@163.com

Overall Officials

Name	Affiliation	Role
Ping Li, PHD	Beijing Anzhen Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital	Recruiting	Beijing		100029	China

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided