Clinical trial NCT04561908: Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access
Official title: Transcatheter Microguidewire Drilling (TMD) for Transseptal Left Atrial Access: First-in-human Use Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Atrial Septal Dilatation
Keywords: transseptal
puncture
microguidewire
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-center, randomized, controlled study
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the safety and efficacy of transcatheter microguidewire drilling (TMD) for transseptal left atrial access in patients with abnormal atrial septal morphology.

Detailed description: Despite the widespread application and decades of experience, Brockenbrough-needle transseptal puncture still risks cardiac perforations and secondary pericardial effusion/tamponade, especially in patients with abnormal atrial septal morphology. To facilitate atrial septal crossing, different methods and devices have been developed, including radiofrequency energy, excimer laser, SafeSept wire and so on. However, these are still limited by availability and cost, and the advantages might be further offset by the potential risks. In addition, these methods are performed mainly with the linear insertion technique, which might result in less forward-force to penetrate atrial septum and displacement of needle-tip. Therefore, it is necessary to develop a safe, available and low-cost transseptal procedure for these patients.

Through a Brockenbrough needle, the hard "back-end" of the microguidewire (0.014-inch) has the potential to drill through the atrial septum with ease. Compared with a standard linear insertion technique, the penetration might be improved and less force is required with the bidirectional rotation technique, and the related risks might be reduced with the modified TSP due to the thin microguidewire. After the passage of the needle, the soft-end of microguidewire can be introduced into left pulmonary superior vein, which can become a safe rail for the introduction of puncture dilator/sheath.

In this study, we examined the effectiveness and safety of microguidewire-assisted TSP for patients with complex atrial septum.

Eligibility criteria: Inclusion Criteria: 1) Patients with atrial septal aneurysm (a bulging of the atrial septum of at least 10 mm beyond the plane of the atrial septum into either the right or left atrium); 2) Or patients with previous multiple transseptal punctures (≧2); 3) Or patients with thickened atrial septum (thickness ≧3 mm); 4) Or patients with enlarged right atrium (≧ 6 cm) and diminished left atrium (\< 3 cm); 5) Or patients with prior mitral valve surgery; 6) Or patients with atrial baffles.

Exclusion Criteria: 1) Associated atrial septal defect or patent foramen ovale; 2) Associated interrupted inferior vena cava; 3) Presence of implanted cardiac devices; 4) Echocardiographic evidence of intracardiac thrombus, mass, tumor or vegetation; 5) Thromboembolic events within the last 6 months; 6) Patients unable to grant informed, written consent.

Primary outcomes:
measure: Procedural Success
timeFrame: 1 Day of procedure
measure: Related-complications
timeFrame: 1 Day of procedure
Secondary outcomes:
measure: Transseptal Access Procedure Time
timeFrame: 1 Day of procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Yan Chaowu
state: Select A State Or Province
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Chaowu Yan, PhD and MD
role: STUDY_CHAIR
References: