Septal MyectomyOPIENCT03094325

On-pump Intraoperative Echocardiography

A study testing Pre Operative On-pump intraoperative echocardiography, Pre Operative Transesophageal echocardiography (TEE) imaging and Post Operative On-pump intraoperative echocardiography in people with Septal Myectomy, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Septal Myectomy
What is being tested?: Pre Operative On-pump intraoperative echocardiography, Pre Operative Transesophageal echocardiography (TEE) imaging and Post Operative On-pump intraoperative echocardiography
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2017to 23 Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

scheduled to receive a septal myectomy.

Who cannot join

Less than 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Official title: On-pump Intraoperative Echocardiography (OPIE)

This pilot study uses an ultrasound probe that is currently clinically used to assess pituitary anatomy, the Hitachi-Aloka high resolution pituitary transducer to measure left ventricular (LV) septal thickness during cardiopulmonary bypass in the performance of surgical septal myectomy. Septal thickness will be assessed and can be visualized during the procedure and if it is likely to improve the efficacy and safety of the procedure. The probe has FDA clearance for a variety of intra-operative surgical procedures but will be off-label for this cardiac surgical protocol.

Conditions: Septal Myectomy
Being tested: Pre Operative On-pump intraoperative echocardiography, Pre Operative Transesophageal echocardiography (TEE) imaging, Post Operative On-pump intraoperative echocardiography, Post Operative Transesophageal echocardiography (TEE) imaging
Keywords: Septal Myectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre Operative On-pump intraoperative echocardiographyDevice
Also called OPIE
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Pre Operative Transesophageal echocardiography (TEE) imagingDevice
Also called TEE
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Post Operative On-pump intraoperative echocardiographyDevice
Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Post Operative Transesophageal echocardiography (TEE) imagingDevice
Center tendency parameters(mean, standard deviation) will be reported for each outcome.

Study groups in NCT03094325
Study group	Role	What they receive
Septal myectomy	Experimental	Not described Receives: Device: Pre Operative On-pump intraoperative echocardiography; Device: Pre Operative Transesophageal echocardiography (TEE) imaging; Device: Post Operative On-pump intraoperative echocardiography; Device: Post Operative Transesophageal echocardiography (TEE) imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Septal Thickness Measured Before Cardiopulmonary Bypass
Center tendency parameters(mean, standard deviation)
Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 201723 Nov 2018

First posted29 Mar 2017
Study start23 Mar 2017
Primary completion30 May 2018
Study completion23 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Septal MyectomyStudies 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03094325
Sponsor's protocol ID: 16-01729
Acronym: OPIE
Status last verified: Mar 2020
First submitted: 23 Mar 2017
Last updated: 31 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: On-pump Intraoperative Echocardiography (OPIE)
ClinicalTrials.gov ID: NCT03094325
Acronym / sponsor ID: OPIE / 16-01729
Conditions: Septal Myectomy
Keywords: Septal Myectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 23 Mar 2017 (actual)
Primary completion: 30 May 2018 (actual)
Study completion: 23 Nov 2018 (actual)
First posted: 29 Mar 2017 (actual)
Results: Posted 31 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Septal myectomy	Experimental	Device: Pre Operative On-pump intraoperative echocardiography, Device: Pre Operative Transesophageal echocardiography (TEE) imaging, Device: Post Operative On-pump intraoperative echocardiography, Device: Post Operative Transesophageal echocardiography (TEE) imaging

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

scheduled to receive a septal myectomy.

Key exclusion criteria (1 listed)

Less than 18 years of age

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
Pre Operative On-pump intraoperative echocardiographyAlso: OPIECenter tendency parameters(mean, standard deviation) will be reported for each outcome.	Device	Septal myectomy
Pre Operative Transesophageal echocardiography (TEE) imagingAlso: TEECenter tendency parameters(mean, standard deviation) will be reported for each outcome.	Device	Septal myectomy
Post Operative On-pump intraoperative echocardiographyCenter tendency parameters(mean, standard deviation) will be reported for each outcome.	Device	Septal myectomy
Post Operative Transesophageal echocardiography (TEE) imagingCenter tendency parameters(mean, standard deviation) will be reported for each outcome.	Device	Septal myectomy

Primary outcome

Septal Thickness Measured Before Cardiopulmonary Bypass
Time frame: 1 Day
Center tendency parameters(mean, standard deviation)

Results and safety

Results posted to the registry on 31 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Partcipants	10	10

Primary outcome: Septal Thickness Measured Before Cardiopulmonary Bypass

Time frame: 1 Day. Mean (Standard Deviation). Unit: millimeters

Measure	TEE Measured Septal Thickness Before Cardiopulmonary Bypass n = 10	OPIE Measured Thickness Before Cardiopulmonary Bypass n = 10
Value	22.9 (4.6)	22.5 (3.5)

Adverse events

Time frame: 1 year after cardiopulmonary bypass procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TEE Measured Septal Thickness Before Cardiopulmonary Bypass	0 of 10 (0%)	0 of 10 (0%)	0 of 10
OPIE Measured Thickness Before Cardiopulmonary Bypass	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 principal investigator

New York University Medical Center Institutional Review Boards

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 31 Mar 2020. 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?

Yes. Results are posted in the registry (first posted 31 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Septal Thickness Measured Before Cardiopulmonary Bypass (time frame: 1 Day). 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 NCT03094325.

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 31 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.