Trial Outcomes & Findings for Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) (NCT NCT00547729)
NCT ID: NCT00547729
Last Updated: 2021-09-02
Results Overview
Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
6 Weeks
Results posted on
2021-09-02
Participant Flow
A total of 71 subjects were enrolled. The adverse events (both serious and non-serious) during the entire period of the study were evaluated in 71 subjects.
Participant milestones
| Measure |
HeartPOD™ System
Implantation of HeartPOD™ System
HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
Baseline characteristics by cohort
| Measure |
HeartPOD™ System
n=71 Participants
Implantation of HeartPOD™ System
HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
|
|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksOut of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.
Outcome measures
| Measure |
HeartPOD™ System
n=55 Participants
Implantation of HeartPOD™ System
HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
|
|---|---|
|
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
|
51 Participants
|
Adverse Events
HeartPOD™ System
Serious events: 68 serious events
Other events: 45 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
HeartPOD™ System
n=71 participants at risk
Implantation of HeartPOD™ System
HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Blood and lymphatic system disorders
False Positive Blood Cultures
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Blood and lymphatic system disorders
Thromboemboli
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Angina
|
19.7%
14/71 • Number of events 16 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Angioplasty
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Atrial Fibrillation with RVR
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Atrioventricular block
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Chest Pain
|
5.6%
4/71 • Number of events 4 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Heart Failure
|
49.3%
35/71 • Number of events 89 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Myocardial Infarction
|
9.9%
7/71 • Number of events 10 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Ventricular Tachycardia
|
12.7%
9/71 • Number of events 14 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Endocrine disorders
Hyperglycemia
|
2.8%
2/71 • Number of events 4 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Endocrine disorders
Hypoglycemia
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Antral gastritis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
2/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Dyspnea
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.4%
1/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Hernia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Melena
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Pleuritic chest pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Body Tingling
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Chest Pain
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Death
|
43.7%
31/71 • Number of events 31 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Dehydration
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Dizziness
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Esophageal Reflux
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Fall
|
2.8%
2/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Fever
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Hypoxia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Lightheadedness
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Pain
|
2.8%
2/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Presyncope
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Stroke
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Syncope
|
14.1%
10/71 • Number of events 10 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Infection
|
9.9%
7/71 • Number of events 11 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Iritis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Osteomyelitis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Sepsis
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Septic Shock
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Viral Syndrome
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Acute hemorrhage/bleeding
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Air emboli
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Cardiac or venous perforation
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Dehydration
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Investigations
Device migration
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Erosion
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Hematoma/seroma formation
|
4.2%
3/71 • Number of events 4 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Lead displacement
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Oversedation
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Pericardial effusion
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Right and Left Atrium Thrombus
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
7.0%
5/71 • Number of events 7 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Syncope
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Device malfunction
|
11.3%
8/71 • Number of events 8 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Fidelis Medtronic RV lead impedance out of range
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Inappropriate ICD Shocks
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Lead Failure
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Pacemaker Mediated Tachycardia
|
1.4%
1/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Sensor Drift
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Psychiatric disorders
Trauma
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Renal and urinary disorders
Prostatism
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Renal and urinary disorders
Renal Failure
|
9.9%
7/71 • Number of events 9 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Renal and urinary disorders
Ureteral Stricture and Dilatation
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Renal and urinary disorders
Urinary Retension
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.4%
1/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Skin and subcutaneous tissue disorders
Abscess
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Atrial Pressure Sensor Revision
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
AV Fistula Creation for Dialysis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Balloon Cystoscopy
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Chemotherapy
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Hysterectomy
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
LVAD Repair
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Percutaneous Mitral Repair
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned CRT implant
|
5.6%
4/71 • Number of events 4 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned CRT replacement
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned Device Revision
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned ICD Implant
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned LVAD Implant
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned Pacemaker Replacement
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned Pulse Generator Replacement
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned Upgrade to CRT
|
1.4%
1/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Surgery
|
2.8%
2/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Carotid Stenosis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Cerebrovascular Accident
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Coronary artery disease
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.4%
1/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Hypotension
|
7.0%
5/71 • Number of events 5 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Stroke
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Transient Ischemic Attack
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
Other adverse events
| Measure |
HeartPOD™ System
n=71 participants at risk
Implantation of HeartPOD™ System
HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Blood and lymphatic system disorders
Epistaxis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Angina
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Chest Pain
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Cardiac disorders
Heart failure
|
5.6%
4/71 • Number of events 5 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Endocrine disorders
Hyperglycemia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Eye disorders
Blurred Vision
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Abdominal Bruising
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Dehydration
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Episode of Vagueness
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Fatigue
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Headache
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
General disorders
Syncope
|
4.2%
3/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Infections and infestations
Infection
|
5.6%
4/71 • Number of events 4 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Acute hemorrhage/bleeding
|
11.3%
8/71 • Number of events 8 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Device migration
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Discomfort at device location
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Hematoma/seroma formation
|
11.3%
8/71 • Number of events 8 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Infection
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Nausea
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Oversedation
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Skin injury
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Injury, poisoning and procedural complications
Wound Tenderness
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Investigations
Abnormal lab results
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Femoral Nerve Irritation
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Hypotension
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Pain
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Paresthesia
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Nervous system disorders
Vasovagal Episode
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Bradycardia due to ICD RV lead dislodgement
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Product Issues
Device Malfunction
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Renal and urinary disorders
Renal Failure
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Cholecystectomy
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Elective Cataract Surgery
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Lightheadedness during Valsalva
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Planned Knee Replacement
|
2.8%
2/71 • Number of events 2 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Surgical and medical procedures
Surgery
|
2.8%
2/71 • Number of events 3 • Subjects were followed for 12 months to evaluate adverse events.
|
|
Vascular disorders
Hypotention
|
1.4%
1/71 • Number of events 1 • Subjects were followed for 12 months to evaluate adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place