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

Randomized Trial of Angioplasty Guidewire-Assisted Transseptal Puncture Technique Versus Conventional Technique for Left Atrial Access in Left Atrial Appendage Occlusion

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture

Detailed Description

Transseptal catheterization is a critical step for left atrial interventions (atrial fibrillation ablation, LA appendage closure, mitral valve interventions). The availability of suitable tools and techniques is essential to safely perform the TSP, effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult procedural situations in which complications may arise. Historically, a conventional Brockenbrough (BRK) needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature. Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.

This study is intended to assess the safety, performance and usability of the angioplasty guidewire in facilitating access to the left atrium during LAAO procedures for the treatment of atrial fibrillation (AF). Moreover, the study will assess the impact of the GW-TSP on procedural times, including time to achieve left atrial accesses, total procedure times, total fluoroscopy time. The study is a prospective, single-blinded, three-center, randomized, controlled trial. Enrolled subjects who meet the study inclusion/exclusion criteria will be evaluated during the LAAO procedures and followed until release from hospital post procedure per institutional standard of care. After 30 days, patient will be contacted by telephone to obtain information on their clinical condition and any adverse events; if necessary, a clinic visit may be performed when required by the physician.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
      • Contact: JUN PU, Doctor; Phone Number: +86 13817577592; Email: pujun310@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Unwilling or unable to comply fully with study procedures and follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: angioplasty guidewire-assisted transseptal group; 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; 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).
Sham Comparator: Conventional transseptal group; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total transseptal puncture time	in minutes and seconds. (Total time required for left atrial access)	Intraprocedural assessment (within 24 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from sheath in superior vena cava to sheath in fossa ovalis	The time that sheath slides from superior vena cava to fossa ovalis	Intraprocedural assessment (measured in seconds)
Time from needle in fossa ovalis to needle in left atrial	The time of sheath needle advancement through the septum and into the left atrial.	Intraprocedural assessment (measured in seconds)
Time from needle in left atrial to sheath in left atrial	Time of needle advancement through the septum to sheath advancement into the left atrial.	Intraprocedural assessment (measured in seconds)
Time from sheath in left atrial to sheath in pulmonary vein	The time that sheath enters the pulmonary vein after advancement into the left atrial.	Intraprocedural assessment (measured in seconds)
Total fluoroscopy time	Total fluoroscopy time	in seconds
Total procedural time	Total procedural time	in minutes
contrast volume	contrast used in transseptal puncture	During or immediately after procedure
Procedure related complication rate	The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture; events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture	Acute peri-procedural complications will be defined as occurring within 30 days of LAAO: during or immediately after procedure, up to 1 day after procedure, up to 30 days after procedure

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: LY Gu, Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji HospitalH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 31, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AGILE-LA Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No