Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Diseases Atrial Septal Dilatation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, single-center, randomized, controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional transseptal puncture

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

Group Type ACTIVE_COMPARATOR

Transseptal puncture with Brockenbrough-needle

Intervention Type DEVICE

Conventional transseptal puncture with Brockenbrough-needle

Microguidewire-assisted transseptal puncture

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.

Group Type EXPERIMENTAL

Microguidewire-assisted transseptal puncture

Intervention Type DEVICE

Microguidewire-assisted transseptal puncture (0.014-inch microguidewire)

Interventions

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Transseptal puncture with Brockenbrough-needle

Conventional transseptal puncture with Brockenbrough-needle

Intervention Type DEVICE

Microguidewire-assisted transseptal puncture

Microguidewire-assisted transseptal puncture (0.014-inch microguidewire)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No