Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04339452
Other study ID # 37481
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 11, 2022
Est. completion date March 2025

Study information

Verified date February 2023
Source Medical College of Wisconsin
Contact Krissa Packard, MS
Phone 4149551861
Email kpackard@mcw.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 2025
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) - Adequate Distal target caliber (as determined by the PI) Exclusion Criteria: - 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 - Insufficient conduit - BMI over 50 - Patients who are COVID-19 positive at the time of screening

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Impella 5.0 and Impella 5.5 with SmartAssist Supported OPCABG
Subjects will undergo insertion of an axillary or ascending aortic Impella 5.0 Device or Impella 5.5 with SmartAssist, followed by Impella supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection.

Locations

Country Name City State
United States The Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Lyle Joyce Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Intraoperative
See also
  Status Clinical Trial Phase
Terminated NCT04066738 - Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Enrolling by invitation NCT02930265 - Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy N/A
Completed NCT01215253 - Ranolazine Implantable Cardioverter-Defibrillator Trial Phase 3
Completed NCT04508608 - Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
Recruiting NCT05888662 - Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT) N/A
Completed NCT03857906 - Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery
Completed NCT02501811 - Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure Phase 2
Recruiting NCT02058771 - Utilising Lifemap to Investigate Malignant Arrhythmia Therapy
Not yet recruiting NCT01946048 - Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy Phase 1
Terminated NCT01759212 - Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure. Phase 2/Phase 3
Not yet recruiting NCT01447069 - Use of Beta-agonists in Stable Severe Congestive Heart Failure N/A
Recruiting NCT00972114 - CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy Phase 1/Phase 2
Completed NCT00896142 - Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation) N/A
Recruiting NCT01076660 - Left Ventricular Structural Predictors of Sudden Cardiac Death
Completed NCT00305214 - MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients N/A
Completed NCT00305240 - MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients N/A
Active, not recruiting NCT00962364 - Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
Recruiting NCT05769036 - Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients N/A
Completed NCT03862339 - The SoundScar Study The SOUNDSCAR Study