Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

NCT03987945 | Unknown DMC

• 1 other identifier: LAAO-SH
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.

Conditions

Atrial Fibrillation; Left Atrial Appendage Occlusion

Keywords

atrial fibrillation; left atrial appendage occlusion

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebral events (MACCE)

  A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events

  From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years

Secondary Outcomes (6)

• All-cause death

  From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years

• Cardiovascular death

  From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years

• Ischemic stroke

  From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years

• Major bleeding

  From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years

• Heart failure rehospitalization

  From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years

Study Arms (1)

Left atrial appendage occlusion

Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure.

Device: left atrial appendage occlusion devices

Interventions

left atrial appendage occlusion devices DEVICE

All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.

Left atrial appendage occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with NVAF who are referred for LAAO procedure.

You may qualify if:

• Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital;
• Adult patients (\>18 years old).

You may not qualify if:

• Patients with rheumatic valvular disease;
• Patients with sick sinus syndrome;
• Patients who had a history of cardiac surgery (i.e., CABG);
• patients who had received the catheter radiofrequency ablation procedure.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yawei Xu, M.D., Ph.D.

  Department of Cardiology, Shanghai Tenth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengmeng Gong, M.D.

CONTACT

+86-188-0179-0469; zoemodi@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 17, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

CN (1)