Angioplasty Guidewire-Assisted Versus Conventional Transseptal Puncture for Left Atrial Appendage Occlusion
NCT ID: NCT05125159
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2021-01-01
2023-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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).
Conventional transseptal group
Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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LY Gu
Role: STUDY_CHAIR
Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji HospitalH
Locations
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Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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JUN PU, Doctor
Role: primary
References
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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.
Other Identifiers
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AGILE-LA Study
Identifier Type: -
Identifier Source: org_study_id