Trial Outcomes & Findings for The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study (NCT NCT04219618)

Results Overview

Perioperative right ventricular (RV) failure is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scoring as the need for intravenous inotropes for \>14 days post-operatively or a right ventricular assist device (RVAD). RV function will be measured by tricuspid annular plane systolic excursion (TAPSE) values assessed using echocardiography. Additionally, hemodynamic evidence of RV dysfunction will also be collected with: a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67. A thrombotic complication is defined as any thromboembolic event (transient ischemic attack or stroke objectively confirmed with computed tomography) or confirmed pump thrombus.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

from time of implantation to 30 days post-implantation

Results posted on

2022-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	On-Pump On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.	Total n=2 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 0 • n=5 Participants	39 years STANDARD_DEVIATION 0 • n=7 Participants	39 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: from time of implantation to 30 days post-implantation

Perioperative right ventricular (RV) failure is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scoring as the need for intravenous inotropes for \>14 days post-operatively or a right ventricular assist device (RVAD). RV function will be measured by tricuspid annular plane systolic excursion (TAPSE) values assessed using echocardiography. Additionally, hemodynamic evidence of RV dysfunction will also be collected with: a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67. A thrombotic complication is defined as any thromboembolic event (transient ischemic attack or stroke objectively confirmed with computed tomography) or confirmed pump thrombus.

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Number of Participants With the Composite Outcome of Moderate or Severe Right Ventricular (RV) Dysfunction (Perioperative Right Heart Failure), Severe Renal Dysfunction Requiring Renal Replacement Therapy, Thrombotic Complications, or Death From Any Cause	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from time of implantation to 48 hours post-implantation

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Number of Participants With a Need for Blood Product Transfusion Within 48-hours Post-implantation	1 Participants	0 Participants

SECONDARY outcome

Timeframe: from time of implantation to 30 days post-implantation

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Operative Safety as Indicated by the Number of Participants Who Died Within 30 Days Post-implantation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from time of implantation to 24 hours post-implantation

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Operative Safety as Indicated by Chest Tube Output Within 24 Hours of Implantation	180 milliliters (mL) Standard Deviation 0	100 milliliters (mL) Standard Deviation 0

SECONDARY outcome

Timeframe: from time of implantation to 30 days post-implantation

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Operative Safety as Indicated by Number of Participants Who Underwent Post-operative Re-exploration for Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post-implantation

Population: Data for this outcome measure were not collected for any participant.

Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post-implantation

Population: Data for this outcome measure were not collected for any participant.

Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: Data for this outcome measure were not collected for any participant.

Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from time of implantation to 1 year post-implantation

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Number of Readmissions for Heart Failure	2 readmissions	0 readmissions

SECONDARY outcome

Timeframe: Baseline

Population: Data for this outcome measure were not collected for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Data for this outcome measure were not collected for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Data for this outcome measure were not collected for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours post-implantation

Population: Data for this outcome measure were not collected for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours post-implantation

Population: Data for this outcome measure were not collected for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours post-implantation

Population: Data for this outcome measure were not collected for any participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days post-implantation

Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Number of Participants With Major Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months post-implantation

Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Number of Participants With Major Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months post-implantation

Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.

Outcome measures

Outcome measures
Measure	On-Pump n=1 Participants On-Pump: A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.	Off-Pump n=1 Participants Off-Pump: After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
Number of Participants With Major Bleeding	0 Participants	0 Participants

Adverse Events

Off-Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

On-Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Igor D. Gregoric, MD

The University of Texas Health Science Center at Houston

Phone: 713-486-6714

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place