Atrial Septal Dilatation, Heart Diseases
Conditions
Keywords
transseptal, puncture, microguidewire
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.
Interventions
DEVICETransseptal puncture with Brockenbrough-needle
Conventional transseptal puncture with Brockenbrough-needle
DEVICEMicroguidewire-assisted transseptal puncture
Microguidewire-assisted transseptal puncture (0.014-inch microguidewire)
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
prospective, single-center, randomized, controlled study
Eligibility
Sex/Gender
ALL
Age
3 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 1 Day of procedure | Number of participants with successful transseptal left atrial access |
| Related-complications | 1 Day of procedure | Pericardial effusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transseptal Access Procedure Time | 1 Day of procedure | Total amount of procedure time, from the beginning of the transseptal procedure until left atrium access is obtained in each patient. |
Countries
China
Contacts
Primary ContactChaowu Yan, PhD and MD
Backup ContactShiguo Li, PhD and MD
Outcome results
None listed