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

NCT05125159 | Unknown

• 1 other identifier: AGILE-LA Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Total transseptal puncture time

  in minutes and seconds. (Total time required for left atrial access)

  Intraprocedural assessment (within 24 hours)

Secondary Outcomes (8)

• Time from sheath in superior vena cava to sheath in fossa ovalis

  Intraprocedural assessment (measured in seconds)

• Time from needle in fossa ovalis to needle in left atrial

  Intraprocedural assessment (measured in seconds)

• Time from needle in left atrial to sheath in left atrial

  Intraprocedural assessment (measured in seconds)

• Time from sheath in left atrial to sheath in pulmonary vein

  Intraprocedural assessment (measured in seconds)

• Total fluoroscopy time

  in seconds

Study Arms (2)

angioplasty guidewire-assisted transseptal group

EXPERIMENTAL

Patients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance.

Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture

Conventional transseptal group

SHAM COMPARATOR

Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical).

Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture

Interventions

angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture PROCEDURE

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).

Conventional transseptal group; angioplasty guidewire-assisted transseptal group

Eligibility Criteria

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

You may qualify if:

• Patient is referred to receive a LAAO procedure for atrial fibrillation, requiring transseptal access and LA catheterization
• Patients greater than 18 years of age
• Patient has signed the informed consent form and is willing to participate in the clinical study and data collection

You may not qualify if:

• Previous left atrial (LA) ablation or LA surgery
• Active Intracardiac Thrombus
• Pre-existing pulmonary vein stenosis or PV stent
• Pre-existing hemidiaphragmatic paralysis
• Contraindication to anticoagulation or radiocontrast materials
• Cardiac valve prosthesis
• Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
• Cardiac surgery during the three-month interval preceding the consent date
• Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
• Significant chronic kidney disease (CKD - eGFR \<30 µMol/L)
• Uncontrolled hyperthyroidism
• Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
• Pregnancy
• Life expectancy less than one year
• Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• Hu F, Xu B, Qiao Z, Cheng F, Zhou Z, Zou Z, Zang M, Ding S, Hong J, Xie Y, Zhou Y, Huang J, Pu J. Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion: a multicentre randomized controlled trial. Europace. 2023 Dec 6;25(12):euad349. doi: 10.1093/europace/euad349.

  PMID: 38011331 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• LY Gu

  Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji HospitalH

  STUDY CHAIR

Central Study Contacts

Jun Pu, Doctor

CONTACT

13817577592; Pujun310@hotmail.com

Song Ding, Doctor

CONTACT

13917180312; dingsong1105@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 18, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 18, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)