Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access (TMD)

National Center for Cardiovascular Diseases

Status: Unknown

Conditions: Atrial Septal Dilatation; Heart Diseases

Treatments: Device: Transseptal puncture with Brockenbrough-needle; Device: Microguidewire-assisted transseptal puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04561908

2020-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Conventional transseptal puncture

Active Comparator group

Description:

Under the guidance of fluoroscopy and echocardiography, transseptal puncture was performed with Brockenbrough-needle.

Treatment:

Device: Transseptal puncture with Brockenbrough-needle

Microguidewire-assisted transseptal puncture

Experimental group

Description:

The Brockenbrough needle, with transseptal dilator and sheath, was introduced into the right atrium and engaged in the fossa ovalis, which was confirmed with angiographical and echocardiographical "tenting sign". 1) the hard-end of a 0.014-inch microguidewire drilled through atrial septum through Brockenbrough-needle; 2) then the needle was advanced into left atrium over the fixed microguidewire; 3) finally the soft-end of microguidewire was introduced into left atrium/left superior pulmonary vein through Brockenbrough-needle, which was further advanced over the fixed microguidewire.

Treatment:

Device: Microguidewire-assisted transseptal puncture