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

NCT ID: NCT04108169

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-01-31

Brief Summary

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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

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Conditions

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Heart Surgery

Keywords

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Coronary artery bypass graft Left Atrial Appendage Occlusion stroke prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Active Comparator

Group Type ACTIVE_COMPARATOR

Left atrial appendage occlusion surgery

Intervention Type PROCEDURE

CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage

Sham Comparator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Left atrial appendage occlusion surgery

CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Institute of Heart, Lung and Blood Vessel Diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ping Li, PHD

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yulin Li, PHD

Role: CONTACT

Phone: 86-010-64426153

Email: [email protected]

Ping Li, PHD

Role: CONTACT

Email: [email protected]

Facility Contacts

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ke-xu Yang

Role: primary

Other Identifiers

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20190926

Identifier Type: -

Identifier Source: org_study_id