Ischemic CardiomyopathyNCT04339452
Impella Supported OPCABG
An observational study of Ischemic Cardiomyopathy, run by Lucian Archambault Durham III at 1 site in United States.
Trial summary
The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- Impella 5.5 with SmartAssist Supported OPCABG
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to Mar 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients fitting inclusion criteria will undergo Impella supported OPCABG using coronary shunts. Inclusion criteria will target patients with ischemic cardiomyopathy, similarly defined to the STICH trial which evaluated coronary revascularization in the setting of heart failure (defined by an EF≤35%). Patients would be considered for enrollment in the setting of symptomatic severe multi-vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon).
Who may be able to join
- Age ≥ 18 years old
- Ejection fraction ≤ 35%
- Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or Left main disease
- Adequate Distal target caliber (as determined by the PI or operating surgeon)
Who cannot join
- Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:
- Patients with structural heart disease requiring cardiopulmonary bypass
- Patients with cardiogenic shock who require a period of short-term mechanical circulatory support
- Patients with mechanical aortic valve
- Patients with previous median sternotomy
- Patients with evidence of non-viability on preoperative cardiac MRI or CT scan
Show all 9Show fewer
- Insufficient conduit
- BMI over 50
- Suspected or known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: a Single Center Prospective Observational Study
The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- Impella 5.5 with SmartAssist Supported OPCABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella 5.5 with SmartAssist Supported OPCABGDevice
Subjects will undergo insertion of an axillary or ascending aortic Impella 5.5 with SmartAssist, followed by Impella-supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hemodynamic stability
Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start11 May 2022
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucian Archambault Durham III
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Sponsor-investigator, Lucian Archambault Durham III, Medical College of Wisconsin
- Investigators
- Lucian A Durham, MD, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339452
- Sponsor's protocol ID
- 37481
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2020
- Last updated
- 27 Jan 2025
- 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: a Single Center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04339452
- Acronym / sponsor ID
- 37481
- Conditions
- Ischemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lucian Archambault Durham IIIUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- 11 May 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Apr 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.
The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients fitting inclusion criteria will undergo Impella supported OPCABG using coronary shunts. Inclusion criteria will target patients with ischemic cardiomyopathy, similarly defined to the STICH trial which evaluated coronary revascularization in the setting of heart failure (defined by an EF≤35%). Patients would be considered for enrollment in the setting of symptomatic severe multi-vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon).
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Ejection fraction ≤ 35%
- Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or Left main disease
- Adequate Distal target caliber (as determined by the PI or operating surgeon)
Key exclusion criteria (9 listed)
- Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:
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 |
|---|---|---|
| Impella 5.5 with SmartAssist Supported OPCABGSubjects will undergo insertion of an axillary or ascending aortic Impella 5.5 with SmartAssist, followed by Impella-supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection. | Device | – |
Primary outcome
Intraoperative hemodynamic stability
Time frame: Intraoperative
Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time.
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 27 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
RecruitingObservational study
The Multicenter Cardiology Monitoring Platform Registry
Heart Failure, Cardiomyopathies
Recruiting
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease, Heart Failure Systolic
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.
Lucian A Durham, MD, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy, run by Lucian Archambault Durham III 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 4 inclusion and 9 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 27 Jan 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?
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?
Intraoperative hemodynamic stability (time frame: Intraoperative). 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 27 Jan 2025.