Heart DiseasesTMDNCT04561908
Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access
A study testing Transseptal puncture with Brockenbrough-needle and Microguidewire-assisted transseptal puncture in people with Heart Diseases and Atrial Septal Dilatation, run by China National Center for Cardiovascular Diseases at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- Heart Diseases, Atrial Septal Dilatation
- What is being tested?
- Transseptal puncture with Brockenbrough-needle and Microguidewire-assisted transseptal puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 4 Sep 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, 100037
Chaowu Yan, PhD and MD
- Recruiting
Yan Chaowu
Beijing, Select A State Or Province, 100037
Chaowu Yan, PhD and MD, +861088398408, chaowuyan@163.com
Chaowu Yan, PhD and MD
About this study
Official title: Transcatheter Microguidewire Drilling (TMD) for Transseptal Left Atrial Access: First-in-human Use Study
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.
Read the 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.
- Conditions
- Heart Diseases, Atrial Septal Dilatation
- Being tested
- Transseptal puncture with Brockenbrough-needle, Microguidewire-assisted transseptal puncture
- Keywords
- transseptal, puncture, microguidewire
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transseptal puncture with Brockenbrough-needleDevice
Conventional transseptal puncture with Brockenbrough-needle
Microguidewire-assisted transseptal punctureDevice
Microguidewire-assisted transseptal puncture (0.014-inch microguidewire)
| Study group | Role | What they receive |
|---|---|---|
| Conventional transseptal puncture | Active comparator | Under the guidance of fluoroscopy and echocardiography, transseptal puncture was performed with Brockenbrough-needle. Receives: Device: Transseptal puncture with Brockenbrough-needle |
| Microguidewire-assisted transseptal puncture | Experimental | 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. Receives: Device: Microguidewire-assisted transseptal puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Number of participants with successful transseptal left atrial access
Measured: 1 Day of procedure
Related-complications
Pericardial effusion
Measured: 1 Day of procedure
Secondary outcomes (1)
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.
Measured: 1 Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start4 Sep 2020
- Primary completion4 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, single-center, randomized, controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chaowu Yan, PhD and MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561908
- Sponsor's protocol ID
- 2020-5
- Acronym
- TMD
- Status last verified
- Apr 2022
- First submitted
- 20 Sep 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Microguidewire Drilling (TMD) for Transseptal Left Atrial Access: First-in-human Use Study
- ClinicalTrials.gov ID
- NCT04561908
- Acronym / sponsor ID
- TMD / 2020-5
- Conditions
- Heart Diseases, Atrial Septal Dilatation
- Keywords
- transseptal, puncture, microguidewire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 4 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, single-center, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Conventional transseptal puncture | Active comparator | Device: Transseptal puncture with Brockenbrough-needleUnder the guidance of fluoroscopy and echocardiography, transseptal puncture was performed with Brockenbrough-needle. |
| Microguidewire-assisted transseptal puncture | Experimental | Device: Microguidewire-assisted transseptal punctureThe 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. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transseptal puncture with Brockenbrough-needleConventional transseptal puncture with Brockenbrough-needle | Device | Conventional transseptal puncture |
| Microguidewire-assisted transseptal punctureMicroguidewire-assisted transseptal puncture (0.014-inch microguidewire) | Device | Microguidewire-assisted transseptal puncture |
Primary outcome
Procedural Success
Time frame: 1 Day of procedure
Number of participants with successful transseptal left atrial access
Related-complications
Time frame: 1 Day of procedure
Pericardial effusion
1 secondary outcome
Transseptal Access Procedure Time
Time frame: 1 Day of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaowu Yan, PhD and MD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transseptal puncture with Brockenbrough-needle and Microguidewire-assisted transseptal puncture in people with Heart Diseases and Atrial Septal Dilatation, run by China National Center for Cardiovascular Diseases at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaowu Yan, PhD and MD (+861088398408, chaowuyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: 1 Day of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.