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Angioplasty Guidewire-Assisted Versus Conventional Transseptal Puncture for Left Atrial Appendage Occlusion

NCT05125159 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-11-18

No results posted yet for this study

Summary

This will be a prospective, single-blinded, three-center, randomized, controlled trial comparing the effectiveness and safety of angioplasty guidewire-assisted transseptal puncture (GW-TSP) technique to transseptal left atrial (LA) access with conventional transseptal puncture with standard transseptal equipment (CON-TSP) in patients undergoing left atrial appendage occlusion (LAAO) procedure for atrial fibrillation. The targeted population will consist of patients with atrial fibrillation undergoing LAAO.

Conditions

Interventions

PROCEDURE

angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture

Patients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance. Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical).

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • LY Gu · Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji HospitalH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-01-01
Completion
2023-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125159 on ClinicalTrials.gov