Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access

Heart Diseases Clinical Trial

— TMD  

Official title:

Transcatheter Microguidewire Drilling (TMD) for Transseptal Left Atrial Access: First-in-human Use Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561908
• Other study ID #: 2020-5
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Chaowu Yan, PhD and MD
• Phone: +861088398408
• Email: chaowuyan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: September 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Septal Dilatation
• Heart Diseases

Intervention

Device:
• Transseptal puncture with Brockenbrough-needle
Conventional transseptal puncture with Brockenbrough-needle
• Microguidewire-assisted transseptal puncture
Microguidewire-assisted transseptal puncture (0.014-inch microguidewire)

Locations

Country	Name	City	State
China	National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital	Beijing	Beijing
China	Yan Chaowu	Beijing	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Success	Number of participants with successful transseptal left atrial access	1 Day of procedure
Primary	Related-complications	Pericardial effusion	1 Day of procedure
Secondary	Transseptal Access Procedure Time	Total amount of procedure time, from the beginning of the transseptal procedure until left atrium access is obtained in each patient.	1 Day of procedure