Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atrial Septal Dilatation
- Heart Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 3 years and 99 years
- Gender
- Both males and females
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 method...
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. In this study, the hard-end of 0.014-inch microguidewire is used to drill through atrial septum through a 6F-guidecatheter. Over the fixed microguidewire, a 3.0 or 3.5-mm balloon is advanced to override atrial septum (proximal balloon within guidecatheter and distal balloon in left atrium). During balloon-dilation, the guidecatheter and balloon is advanced gently into left atrium as a unit over the fixed microguidewire. The study is conducted to evaluate the feasibility and safety of transcatheter microguidewire drilling (TMD) for transseptal left atrial access.
Tracking Information
- NCT #
- NCT04561908
- Collaborators
- Not Provided
- Investigators
- Study Chair: Chaowu Yan, PhD and MD Chinese Academy of Medical Sciences, Fuwai Hospital