Atrial Fibrillation Clinical Trial
Official title:
Randomized Trial of Angioplasty Guidewire-Assisted Transseptal Puncture Technique Versus Conventional Technique for Left Atrial Access in Left Atrial Appendage Occlusion
Verified date | January 2021 |
Source | RenJi Hospital |
Contact | Jun Pu, Doctor |
Phone | 13817577592 |
Pujun310[@]hotmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total transseptal puncture time | in minutes and seconds. (Total time required for left atrial access) | Intraprocedural assessment (within 24 hours) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Total fluoroscopy time | Total fluoroscopy time | in seconds | |
Secondary | Total procedural time | Total procedural time | in minutes | |
Secondary | contrast volume | contrast used in transseptal puncture | During or immediately after procedure | |
Secondary | 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 |
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