NCT05086653

Brief Summary

The following case reported a rare complication of left atrial appendage perforation complicated by cardiac tamponade during LAAO device deployment and its corresponding surgical management

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

September 27, 2021

Last Update Submit

October 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment related adverse events

    Three months

Interventions

SurgeryPROCEDURE

Sutured by Prolene 3-0 with two layers of pledge

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

one female patient involved

You may qualify if:

  • year-old woman with CHA2DS2-VASc score 4

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Division of Cardiovascular Surgery

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Atrial FibrillationCardiac Tamponade

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general practitioner

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 21, 2021

Study Start

June 20, 2020

Primary Completion

July 20, 2020

Study Completion

October 25, 2020

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

This is a case report

Locations