Heart FailureMicrotech-LVADNCT06682910
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
A study testing Microtech sensor pressure in people with Heart Failure, run by Microtech Medical Technologies, Ltd at 2 sites in 2 countries.
Trial summary
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Microtech sensor pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center.
- Patient is characterized as INTERMACS profile 2 or greater.
- Patient is able and willing to provide written informed consent.
- Patient is willing and able to comply with all required post-procedure follow-up visits.
Who cannot join
- Pre-operative coagulopathy or thrombocytopenia
- For an intended LA implant, patient has a device implanted in the left atrial appendage (e.g., WATCHMAN or similar device) or a mechanical mitral valve
- Patient has an atrial myxoma
- Patient has pre-operative evidence of thrombus in the chamber in which the device is intended to be implanted
- Patient has a history of stroke or transient ischemic attack within 6 months prior to the index procedure
- History of systemic or pulmonary thromboembolism or deep vein thrombosis (DVT) within the last 6 months
Show all 16Show fewer
- Patient has a history of congenital heart disease, including known atrial septal defect that is not corrected (including during the LVAD implantation procedure)
- Patient has severe mitral regurgitation (for an LA implant) or severe tricuspid regurgitation (for an RA implant) that is not intended to be corrected during the LVAD implantation
- Patient has known allergy to stainless steel or titanium
- Patient has noncardiac comorbidity that, in the opinion of the Principal Investigator, may limit life expectancy to less than 1 year
- Patient is pregnant or intends to become pregnant prior to completion of all protocol follow-up requirements
- Patient is participating in another investigational study that has not reached its primary endpoint
- Intraoperative identification of any anatomical finding that would preclude safe access to, or closure of, the intended atrial chamber, or fixation of the device within the chamber including, but not limited to:
- Identification of thrombus in the atrium in which the device will be implanted
- Atrial anatomy deemed to be too thin or fragile to accept the implant
- Epicardial adhesions or any intraoperative finding that would complicate access or closure of the atrium in which the device is intended to be implanted
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH
New York, New York, 10032
About this study
Official title: An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA
Read the detailed description
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA. Clinical data will be collected pre-operatively, intra-operatively, throughout the post-operative hospitalization period, at discharge and at 1, 3-6, 9 and 12 months post-index procedure
- Conditions
- Heart Failure
- Being tested
- Microtech sensor pressure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microtech sensor pressureDevice
Microtech sensor implantation
| Study group | Role | What they receive |
|---|---|---|
| Microtech System | Experimental | Microtech System Receives: Device: Microtech sensor pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Efficacy Endpoint
- Successful deployment of the intracardiac sensor.
- Freedom from failure of the Microtech System to obtain valid intracardiac pressures by at least one method (CW/DB), in at least one timepoint up to 6 months.
Measured: 6 months
Co-Primary Safety Endpoint
- Anatomic stability of the implant assessed by echocardiographic imaging through 1 month.
- The incidence of device- or implant procedure-related adverse events through 1 month
Measured: 1 month
Secondary outcomes (7)
The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant
The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant. A "valid" pressure measurement will be defined as a signal for which the system indicates a "fidelity score" >0.7. Details of the fidelity score are provided in the protocol
Measured: 1 month
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter (PAC; LAP from Microtech compared to PCWP from PAC, and RAP from Microtech and RAP from PAC or superior vena caval central line) at baseline and at a follow up between 3- and 6-months post implantation
Measured: pre procedure, 3-6 months
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter (LAP from Microtech compared to PCWP from PAC, and RAP from Microtech and RAP from PAC or superior vena caval central line) at all follow visits from which data are available throughout the 1 year follow up period
Measured: 1 year
Anatomic stability of the implant over the observation period
Anatomic stability of the implant over the observation period, assessed by echocardiographic imaging at post-op, 1, 3-6, 9, 12 months follow-up visits
Measured: post operation, 1 month, 3-6 months, 9 months, 12 months
The incidence of device-related adverse events
The incidence of device-related adverse events through 1 year follow-up
Measured: 12 months
Correlation of changes of sensor-measured atrial pressure
Correlation of changes of sensor-measured atrial pressure with the following clinical parameters performed on the 1, 3-6, 9 and 12 month follow up visits:
- changes of NTproBNP
- changes of KCCQ
- episodes of heart failure exacerbations
- LVAD suction events
- clinical assessments consistent with hypovolemia
- changes in pressure measurements during RPM ramp tests
Measured: 1 month, 3-6 months , 9months and 12 month
Usability of the system
Usability of the system in order to obtain pressure measurements (Human Factors testing) at baseline, 3-6 months and 12 months visits
Measured: baseline, 30-6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microtech Medical Technologies, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682910
- Sponsor's protocol ID
- Microtech-001
- Acronym
- Microtech-LVAD
- Status last verified
- Aug 2026
- First submitted
- 6 Nov 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT06682910
- Acronym / sponsor ID
- Microtech-LVAD / Microtech-001
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Microtech Medical Technologies, LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA
Detailed description
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA. Clinical data will be collected pre-operatively, intra-operatively, throughout the post-operative hospitalization period, at discharge and at 1, 3-6, 9 and 12 months post-index procedure
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microtech System | Experimental | Device: Microtech sensor pressureMicrotech System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center.
- Patient is characterized as INTERMACS profile 2 or greater.
- Patient is able and willing to provide written informed consent.
- Patient is willing and able to comply with all required post-procedure follow-up visits.
Key exclusion criteria (16 listed)
- Pre-operative coagulopathy or thrombocytopenia
- For an intended LA implant, patient has a device implanted in the left atrial appendage (e.g., WATCHMAN or similar device) or a mechanical mitral valve
- Patient has an atrial myxoma
- Patient has pre-operative evidence of thrombus in the chamber in which the device is intended to be implanted
- Patient has a history of stroke or transient ischemic attack within 6 months prior to the index procedure
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 |
|---|---|---|
| Microtech sensor pressureMicrotech sensor implantation | Device | Microtech System |
Primary outcome
Co-Primary Efficacy Endpoint
Time frame: 6 months
1. Successful deployment of the intracardiac sensor. 2. Freedom from failure of the Microtech System to obtain valid intracardiac pressures by at least one method (CW/DB), in at least one timepoint up to 6 months.
Co-Primary Safety Endpoint
Time frame: 1 month
1. Anatomic stability of the implant assessed by echocardiographic imaging through 1 month. 2. The incidence of device- or implant procedure-related adverse events through 1 month
7 secondary outcomes
The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant
Time frame: 1 month
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
Time frame: pre procedure, 3-6 months
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
Time frame: 1 year
Anatomic stability of the implant over the observation period
Time frame: post operation, 1 month, 3-6 months, 9 months, 12 months
The incidence of device-related adverse events
Time frame: 12 months
Correlation of changes of sensor-measured atrial pressure
Time frame: 1 month, 3-6 months , 9months and 12 month
Usability of the system
Time frame: baseline, 30-6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microtech sensor pressure in people with Heart Failure, run by Microtech Medical Technologies, Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. 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 United States, Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-Primary Efficacy Endpoint (time frame: 6 months). 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 21 Aug 2026.