Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.
Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations.
Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Experimental | Implantation of HAART 300 Annuloplasty Device for aortic valve repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAART 300 Annuloplasty Device | Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure | 6 months | |
| Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability. |
Not provided
Inclusion Criteria:
Subject is 18 years of age or older
Subject has tri-leaflet aortic valve morphology
Subject has documented aortic valve disease which may or may not include:
Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
Subject has reviewed and signed the written informed consent form
Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dominico Mazzitelli, MD | Munchen Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical and Experimental Medicine | Prague | 140 21 | Czechia | |||
| German Heart Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HAART 300 Annuloplasty Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-month Primary Endpoint |
|
| ||||||||||||||||||||||||
| 2-year Extended Follow-up |
|
Participants with implanted device
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HAART 300 Annuloplasty Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
Through 2 years for the 49 participants receiving the implant
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HAART 300 Annuloplasty Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| angina pectoris | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Wheeler | Biostable Science and Engineering, Inc. | 512-386-1996 | John.wheeler@biostable-s-e.com |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| discharge or 14 days postprocedure, whichever comes first |
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months | 6 months |
| Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure | 2 years |
| Aortic Insufficiency (AI) at 2 Years | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 2 years |
| New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | 6 months |
| New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | 2 years |
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 6 months |
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 2 years |
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 6 months |
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline and 2 years |
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline and 6 months |
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline and 2 years |
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 6 months |
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 2 years |
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 6 months |
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline and 2 years |
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline and 6 months |
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline and 2 years |
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline and 6 months |
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline and 2 years |
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline and 6 months |
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline and 2 years |
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline and 6 months |
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline and 2 years |
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline and 6 months |
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline and 2 years |
| Berlin |
| 80636 |
| Germany |
| Uniklinik Köln | Cologne | 50937 | Germany |
| Klinik für Herz und Gefässchirurgie | Freiburg im Breisgau | 79106 | Germany |
| Klinik und Poliklinik für Herz- und Gefäßchirurgie | Hamburg | 20246 | Germany |
| Hannover Medical School (MHH) | Hanover | 30625 | Germany |
| Munchen Heart Center | München | Germany |
| Klinikum Nürnberg Süd | Nuremberg | 90471 | Germany |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Aortic Insufficiency | Grade assigned to degree of aortic regurgitation determined by core laboratory analysis of echocardiogram: 0=None/trace, 1+=Mild, 2+=Moderate, 3+=Moderate-to-Severe, 4+=Severe | Number | participants |
|
| New York Heart Association (NYHA) Functional Capacity | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked imitation; Class IV - inability to carry out any physical activity without discomfort | Number | participants |
|
| Peak gradient | Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | mm Hg |
|
| Mean gradient | Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | mm Hg |
|
| Left ventricular (LV) mass | Left ventricular mass. Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | g |
|
| Left ventricular internal dimension (LVID) diastole | Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | cm |
|
| LVID systole | Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | cm |
|
| LV diastolic volume | Left ventricular diastolic volume. Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | ml |
|
| LV systolic volume | Left ventricular systolic volume. Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | ml |
|
| Left ventricular ejection fraction (LVEF) | Left ventricular ejection fraction. Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | % |
|
| Cardiac output | Echocardiographic parameter determined by core laboratory. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | l/min |
|
| Cardiac index | Cardiac index is the cardiac output divided by body surface area. | Participants with an echocardiogram evaluable for this measure. | Mean | Standard Deviation | l/min/m^2 |
|
|
| Primary | Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | Participants with an echocardiogram evaluable for this measure. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability. | Posted | Number | 95% Confidence Interval | percentage of implant procedures | discharge or 14 days postprocedure, whichever comes first |
|
|
|
| Secondary | Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| Secondary | Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Secondary | Aortic Insufficiency (AI) at 2 Years | Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | Participants with an echocardiogram evaluable for this measure. | Posted | Number | participants | 2 years |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Capacity Classification at 6 Months | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | Participants with an evaluation of this measure. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Capacity Classification at 2 Years | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | Participants with an evaluation of this measure. | Posted | Number | participants | 2 years |
|
|
|
| Secondary | Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 2 years |
|
|
|
| Secondary | Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
|
|
| Secondary | Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 2 years |
|
|
|
| Secondary | LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | g | Baseline and 6 months |
|
|
|
| Secondary | LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | g | Baseline and 2 years |
|
|
|
| Secondary | LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | cm | Baseline and 6 months |
|
|
|
| Secondary | LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | cm | Baseline and 2 years |
|
|
|
| Secondary | LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | cm | Baseline and 6 months |
|
|
|
| Secondary | LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | cm | Baseline and 2 years |
|
|
|
| Secondary | LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | ml | Baseline and 6 months |
|
|
|
| Secondary | LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | ml | Baseline and 2 years |
|
|
|
| Secondary | LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | ml | Baseline and 6 months |
|
|
|
| Secondary | LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | ml | Baseline and 2 years |
|
|
|
| Secondary | LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Error | percentage of blood volume | Baseline and 6 months |
|
|
|
| Secondary | LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | percentage of blood volume | Baseline and 2 years |
|
|
|
| Secondary | Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | l/min | Baseline and 6 months |
|
|
|
| Secondary | Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | l/min | Baseline and 2 years |
|
|
|
| Secondary | Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Participants with an echocardiogram evaluable for this measure at baseline and at 6 months. | Posted | Mean | Standard Deviation | l/min/m^2 | Baseline and 6 months |
|
|
|
| Secondary | Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Participants with an echocardiogram evaluable for this measure at baseline and at 2 years. | Posted | Mean | Standard Deviation | l/min/m^2 | Baseline and 2 years |
|
|
|
| 23 |
| 49 |
| 38 |
| 49 |
| aortic insufficiency | Cardiac disorders | Systematic Assessment |
|
| arrhythmia | Cardiac disorders | Systematic Assessment |
|
| cardiac decompensation | Cardiac disorders | Systematic Assessment |
|
| pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| syncope | Cardiac disorders | Systematic Assessment |
|
| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| reflux esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| endocarditis | Infections and infestations | Systematic Assessment |
|
| systemic inflammatory response syndrome | Infections and infestations | Systematic Assessment |
|
| worsening of wound healing disorder | Infections and infestations | Systematic Assessment |
|
| wound infection | Infections and infestations | Systematic Assessment |
|
| bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
|
| loosening of wire cerclages | Injury, poisoning and procedural complications | Systematic Assessment |
|
| presternal abscess | Injury, poisoning and procedural complications | Systematic Assessment |
|
| lumbago | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| renal failure | Renal and urinary disorders | Systematic Assessment |
|
| bronchopulmonary infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pleuropneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pulmonary spasticity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| aortic insufficiency | Cardiac disorders | Systematic Assessment |
|
| arrhythmia | Cardiac disorders | Systematic Assessment |
|
| edema | Cardiac disorders | Systematic Assessment |
|
| pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| syncope | Cardiac disorders | Systematic Assessment |
|
| abnormal LDH value | Endocrine disorders | Systematic Assessment |
|
| hyperthyreosis | Endocrine disorders | Systematic Assessment |
|
| increased C-reactive protein | Infections and infestations | Systematic Assessment |
|
| bleeding event | Injury, poisoning and procedural complications | Systematic Assessment |
|
| sternal pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| thoracic pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Publication by the investigator was not allowed until completion of the trial. All proposed publications must be cleared by unanimous vote of a publication committee consisting of the sponsor and representatives of the study investigators. Publication materials must be submitted for review at least 60 day in advance of publication. The Sponsor may embargo publication for 60 additional days to allow for patent filing or may prevent publication if filling of such application would be premature.
| Title | Measurements |
|---|
|
| 3+ |
|
| 4+ |
|
| Title | Measurements |
|---|
|
| 3+ |
|
| 4+ |
|
| Title | Measurements |
|---|
|
| IV |
|
| Title | Measurements |
|---|
|
| IV |
|