Hypertrophic CardiomyopathyNCT04050579
OPIE in the Thin Interventricular Septum
A study testing on-pump intracardiac echocardiography in people with Hypertrophic Cardiomyopathy, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- on-pump intracardiac echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 30 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All hypertrophic cardiomyopathy patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy with a preoperative transthoracic echocardiograph suggesting an interventricular septal width of less than 2.0 cm.
Who cannot join
- Those hypertrophic cardiomyopathy patients who are scheduled to receive a septal myectomy who are less than 18 years old or whose preoperative transthoracic echocardiograph suggests an interventricular septal width of greater than 2.0 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Trial of On-pump Intracardiac Echocardiography (OPIE) in the Thin Interventricular Septum
This is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. OPIE may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. We therefore propose a study in which OPIE is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. Subjects will receive the same perioperative care regardless of their involvement in the study. Patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- on-pump intracardiac echocardiography
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-pump intracardiac echocardiographyDevice
Subjects will be patients with hypertrophic cardiomyopathy with interventricular septae less than 2.0cm who are undergoing septal myectomy. The patients will have already had a number of preoperative transthoracic echocardiographs as part of their normal hypertrophic cardiomyopathy care. Before cardiopulmonary bypass, the basal anterior septal thickness will be measured by transesophageal echocardiograph as is performed in all septal myectomy procedures. The Principal Investigator will then use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated. The post-myectomy anterior basilar septal thickness will again be measured by transesophageal echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| OPIE in thin inverventricular septum | Other | The Principal Investigator use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated. Receives: Device: on-pump intracardiac echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlations
correlation between OPIE and traditional imaging methods
Measured: at the conclusion of all data collection; approximately 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start15 Sep 2020
- Primary completion20 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Why it stopped: Study was determined to be focused on Quality Assurance (QA) and Quality Improvement (QI), rather than research, based on its primary purpose and activities. Study was closed prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Swistel, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050579
- Sponsor's protocol ID
- s19-01180
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2019
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with New York University Langone Health. Requests may be directed to: daniel.swistel@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Williams DM, Nampi RG, Saric M, Grossi EA, Sherrid MV, Swistel DG. A novel imaging modality to guide septal myectomy for hypertrophic cardiomyopathy. Podium presentation at the Western Thoracic Surgical Society Association Annual Meeting. Squaw Valley, CA. June 28, 2019.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Trial of On-pump Intracardiac Echocardiography (OPIE) in the Thin Interventricular Septum
- ClinicalTrials.gov ID
- NCT04050579
- Acronym / sponsor ID
- s19-01180
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was determined to be focused on Quality Assurance (QA) and Quality Improvement (QI), rather than research, based on its primary purpose and activities. Study was closed prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 8 Aug 2019 (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 is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. OPIE may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. We therefore propose a study in which OPIE is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. Subjects will receive the same perioperative care regardless of their involvement in the study. Patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPIE in thin inverventricular septum | Other | Device: on-pump intracardiac echocardiographyThe Principal Investigator use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All hypertrophic cardiomyopathy patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy with a preoperative transthoracic echocardiograph suggesting an interventricular septal width of less than 2.0 cm.
Key exclusion criteria (1 listed)
- Those hypertrophic cardiomyopathy patients who are scheduled to receive a septal myectomy who are less than 18 years old or whose preoperative transthoracic echocardiograph suggests an interventricular septal width of greater than 2.0 cm.
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 |
|---|---|---|
| on-pump intracardiac echocardiographySubjects will be patients with hypertrophic cardiomyopathy with interventricular septae less than 2.0cm who are undergoing septal myectomy. The patients will have already had a number of preoperative transthoracic echocardiographs as part of their normal hypertrophic cardiomyopathy care. Before cardiopulmonary bypass, the basal anterior septal thickness will be measured by transesophageal echocardiograph as is performed in all septal myectomy procedures. The Principal Investigator will then use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated. The post-myectomy anterior basilar septal thickness will again be measured by transesophageal echocardiography. | Device | OPIE in thin inverventricular septum |
Primary outcome
correlations
Time frame: at the conclusion of all data collection; approximately 6 to 12 months
correlation between OPIE and traditional imaging methods
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- BackgroundWilliams DM, Nampi RG, Saric M, Grossi EA, Sherrid MV, Swistel DG. A novel imaging modality to guide septal myectomy for hypertrophic cardiomyopathy. Podium presentation at the Western Thoracic Surgical Society Association Annual Meeting. Squaw Valley, CA. June 28, 2019.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with New York University Langone Health. Requests may be directed to: daniel.swistel@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Daniel Swistel, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing on-pump intracardiac echocardiography in people with Hypertrophic Cardiomyopathy, run by NYU Langone Health at 1 site in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
correlations (time frame: at the conclusion of all data collection; approximately 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050579, which also lists 1 linked publication.
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 11 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.