Trial Outcomes & Findings for NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation (NCT NCT03015194)
NCT ID: NCT03015194
Last Updated: 2023-08-15
Results Overview
Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria: * Successful LAMPOON traversal and laceration; and * Peak LVOT gradient \< 50 mm Hg; and * Absence of procedural mortality; and * Successful access, delivery, and retrieval of the LAMPOON device system; and * Successful deployment and correct positioning of the first intended device; and * Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Exit from the Cardiac Catheterization Laboratory
Results posted on
2023-08-15
Participant Flow
Protocol enrolled 32 participants, however 2 participants had screen failed.
Participant milestones
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Baseline characteristics by cohort
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
n=30 Participants
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
|
|---|---|
|
Age, Continuous
|
76 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Exit from the Cardiac Catheterization LaboratoryParticipants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria: * Successful LAMPOON traversal and laceration; and * Peak LVOT gradient \< 50 mm Hg; and * Absence of procedural mortality; and * Successful access, delivery, and retrieval of the LAMPOON device system; and * Successful deployment and correct positioning of the first intended device; and * Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Outcome measures
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
n=30 Participants
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE)or intracardiac echocardiography.
|
|---|---|
|
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Successful LAMPOON traversal and laceration
|
30 participants
|
|
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
LVOT gradient <50 mm Hg
|
30 participants
|
|
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Procedure survival
|
30 participants
|
|
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Successful access, delivery, and retrieval of LAMPOON device system
|
30 participants
|
|
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Successful deployment and correct positioning of the first intended device
|
27 participants
|
|
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Freedom from emergency surgery or reintervention related to the device or access procedure
|
22 participants
|
PRIMARY outcome
Timeframe: Exit from the Cardiac Catheterization LaboratoryParticipants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria: * Successful LAMPOON traversal and laceration; and * Peak LVOT gradient \< 30 mm Hg; and * Absence of procedural mortality; and * Successful access, delivery, and retrieval of the LAMPOON device system; and * Successful deployment and correct positioning of the first intended device; and * Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
Outcome measures
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
n=30 Participants
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE)or intracardiac echocardiography.
|
|---|---|
|
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Successful LAMPOON traversal and laceration
|
30 participants
|
|
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
LVOT gradient <30 mm Hg
|
29 participants
|
|
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Procedure survival
|
30 participants
|
|
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Successful access, delivery, and retrieval of LAMPOON device system
|
30 participants
|
|
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Successful deployment and correct positioning of the first intended device
|
30 participants
|
|
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Freedom from emergency surgery or reintervention related to the device or access procedure
|
22 participants
|
Adverse Events
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
Serious events: 30 serious events
Other events: 30 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
n=30 participants at risk
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
10/30 • Number of events 20 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
10.0%
3/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Atrioventricular Block complete
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Bacteremia
|
6.7%
2/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac arrest
|
23.3%
7/30 • Number of events 7 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Perivalvular leak
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiogenic Shock
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Atrial Flutter
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders other-LVOT obstruction post TMVR.
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other -increased mitral valve gradient, TMVR thrombus
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Bronchial infection
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-left apical pseudoaneurism.
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-increased LVOT gradient post TMVR
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-elevated mitral valve gradient ; possible TMVR thrombus
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-perivalvular leak post TMVR
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-perivalvular pseudoaneurysm.
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-mitral valve thrombus
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
tenting of anterior leaflet of mitral valve causing myocardial dysfunction and severe hypotension
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-severe perivalvular leak immediately post TMVR
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders-other-right ventricular apex pseudoaneurysm
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
chest pain-cardiac
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Death NOS
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
Encephalopathy
|
10.0%
3/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
endocarditis infective
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
endocarditis infective
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
3.3%
1/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
fall
|
10.0%
3/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Gastrointestional disorders -other-Toxic Megacolon
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Gastrointestional disorders -other-cholecystitis
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
General disorders and administration site conditions-other-AV fistual bleed.
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
General disorders and administration site conditions-other-AV fistual thrombosed.
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Heart failure
|
30.0%
9/30 • Number of events 16 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Hematoma
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Hepatitis viral
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
hypertension
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Infections and infestations-other-C. Difficile infection
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Infections and infestations-other-septic emboli
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications-other-digoxin toxicity
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications-other-Coumadin toxicity
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Injury, poisoning, and procedureal complications-other-opioid toxicity
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications-other-subtherapeutic INR-coumadin
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-guidewire fracture and separation
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-TMVR embolized
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-TMVR dehiscence
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations-other-explant of TMVR Sapien -3 due to malpositioning, MAC, and LV calcification
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Malaise
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Multi-organ failure
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Myocardial Infarction
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-other-generalized pain with impending death
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
pain
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
13.3%
4/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.7%
2/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory , thoracic and mediastinal disorders-other-pneumonia
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory , thoracic and mediastinal disorders-other-pneumonia with sepsis
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-other-COPD exacerbation
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-other-excessive secretions while intubated.
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Sepsis
|
13.3%
4/30 • Number of events 7 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
Stroke
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Surgical and medical procedures
Surgical and Medical Procedures-others-alcohol septal ablation to treat LVOT obstruction
|
13.3%
4/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Vascular disorder-other-thrombolic event
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Vascular disorders-other-hypotensive shock post cardiac arrest
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
vascular disorders-other-thrombotic event
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Ventricular fibrillation
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Ventricular Tachycardia
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
wound complication
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Wound infection
|
3.3%
1/30 • Number of events 1 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
Other adverse events
| Measure |
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
n=30 participants at risk
The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
13.3%
4/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
4/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
93.3%
28/30 • Number of events 32 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Psychiatric disorders
Anxiety
|
16.7%
5/30 • Number of events 7 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Arterial thromboembolism
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
5/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Bladder Infection
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic systems disorder, other-Elevated WBCs
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Blood bilirubin increased
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Blood lactate dehydrogenase increased
|
23.3%
7/30 • Number of events 7 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders other-LVOT obstruction
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Cardiac disorders other-TMVR perivalvular link
|
16.7%
5/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Cardiac troponin I increase
|
90.0%
27/30 • Number of events 30 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Chest pain - cardiac
|
13.3%
4/30 • Number of events 10 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
conduction disorder
|
16.7%
5/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Psychiatric disorders
Confusion
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Reproductive system and breast disorders
Cough
|
16.7%
5/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Creatinine increased
|
50.0%
15/30 • Number of events 19 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Psychiatric disorders
Delirium
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
dysphagia
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Edema Limbs
|
20.0%
6/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Ejection fraction decreased
|
33.3%
10/30 • Number of events 10 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
Encephalopathy
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Fever
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
General disorders and administration sites, other-AV fistual bleed
|
6.7%
2/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Haptoglobin decrease
|
13.3%
4/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
headache
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Heart failure
|
80.0%
24/30 • Number of events 36 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
hematoma
|
33.3%
10/30 • Number of events 11 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Renal and urinary disorders
hematuria
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Hemolysis
|
40.0%
12/30 • Number of events 12 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Hypertension
|
16.7%
5/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
Hypotension
|
40.0%
12/30 • Number of events 14 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
INR increased
|
40.0%
12/30 • Number of events 17 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-albumin low
|
10.0%
3/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-decreased INR
|
20.0%
6/30 • Number of events 9 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations, other-Calcium decreased
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-sodium low
|
20.0%
6/30 • Number of events 7 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-low magnesium
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-potassium high
|
10.0%
3/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Investigations other-potassium low
|
20.0%
6/30 • Number of events 8 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
53.3%
16/30 • Number of events 20 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Lower gastrointestional hemorrhage
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Malaise
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
General disorders
Pain
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Palpitations
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Pericardial Effusion
|
13.3%
4/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
Platelet Count Decrease
|
93.3%
28/30 • Number of events 34 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
23.3%
7/30 • Number of events 8 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
13.3%
4/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders, other-pulmonary nodule
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediatinal disorders other-Pneumonia
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediatinal disorders other-Tachypnea
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Sinus Bradycardia
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Nervous system disorders
Somnolence
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
thromboembolic event
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Gastrointestinal disorders
Upper gastrointestional hemorrhage
|
10.0%
3/30 • Number of events 3 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Renal and urinary disorders
urinary retention
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Urinary tract infections
|
20.0%
6/30 • Number of events 6 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Vascular disorders
vascular disorders other-bruise
|
13.3%
4/30 • Number of events 4 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Cardiac disorders
Ventricular Tachycardia
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Investigations
White blood cell decreased
|
6.7%
2/30 • Number of events 2 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
|
Infections and infestations
Wound Infection
|
16.7%
5/30 • Number of events 5 • Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.
|
Additional Information
Robert Lederman, M.D. Principal Investigator, NIH, NHLBI
National Heart Lung and Blood Institute (NHLBI)
Phone: 301.402.6769
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place