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The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third.
Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease.
Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid aortic valve for predominant aortic insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Valve Repair | Experimental | Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAART 200 Aortic Valve Annuloplasty Device | Device | Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. | 6 months postprocedure | |
| Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months | Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+) | 6 months postprocedure |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge following 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. |
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Inclusion Criteria:
The subject is 18 years of age or older
The subject has bi-leaflet aortic valve morphology
The subject has documented aortic valve disease which may or may not include:
The subject needs:
The 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
The subject has reviewed and signed the written informed consent form
The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominico Mazzitelli, MD | München Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| München Heart Center | München | Bavaria | 80636 | Germany | ||
| Uniklinik Köln |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25865762 | Derived | Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aortic Valve Repair | Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device . |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-month Primary Endpoint |
|
| |||||||||||||||||||||
| 2-year Extended Follow-up |
|
16 of 20 consented participants received the device
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| ID | Title | Description |
|---|---|---|
| BG000 | Aortic Valve Repair | Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 postprocedure |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aortic Valve Repair | Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device . |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic vlave incompetence | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Wheeler | Biostable Science and Engineering, Inc. | 512-386-1996 | John.wheeler@biostable-s-e.com |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| discharge or 14 days postprocedure, whichever comes first |
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 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 postprocedure |
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 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 | 2 years postprocedure |
| Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure. | 2 years |
| Aortic Insufficiency (AI) at 2 Years | Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | Baseline and 2 years |
| New York Heart Association (NYHA) Functional Capacity Classification | 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 postprocedure |
| NYHA Functional Capacity Classification | 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 postprocedure |
| 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 |
| Left Ventricular (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 |
| Left Ventricular Internal Dimension (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 |
| Left Ventricular Ejection Fraction (LVEF) - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline and 6 months |
| Left Ventricular Ejection Fraction (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 |
| Cologne |
| North Rhine-Westphalia |
| 50937 |
| Germany |
| Klinik und Poliklinik für Herz- und Gefäßchirurgie | Hamburg | 20246 | Germany |
| Klinikum Nürnberg Süd | Nuremberg | 90471 | Germany |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| 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+=Moderately Severe, 4+=Severe | Count of Participants | 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 limitation; Class IV - inability to carry out any physical activity without discomfort | Count of Participants | 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 | percentage of blood volume |
|
| 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 | Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+) | Participants with an echocardiogram evaluable for this measure. | Posted | Count of Participants | Participants | 6 months postprocedure |
|
|
|
| Secondary | Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge following 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 participants | discharge or 14 days postprocedure, whichever comes first |
|
|
|
| Secondary | Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 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 postprocedure |
|
|
|
| Secondary | Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 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 | 2 years postprocedure |
|
|
|
| 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 | Aortic insufficiency assessed by transthoracic echocardiography 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 | Count of Participants | Participants | Baseline and 2 years |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Capacity Classification | 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 | Count of Participants | Participants | 6 months postprocedure |
|
|
|
| Secondary | NYHA Functional Capacity Classification | 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 | Count of Participants | Participants | 2 years postprocedure |
|
|
|
| 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 | Left Ventricular (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 | Left Ventricular Internal Dimension (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 Error | 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 | Left Ventricular Ejection Fraction (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 Deviation | percentage of blood volume | Baseline and 6 months |
|
|
|
| Secondary | Left Ventricular Ejection Fraction (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 |
|
|
|
| 0 |
| 16 |
| 8 |
| 16 |
| 16 |
| 16 |
| Arrhythmia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Chronic lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Aortic dilation | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (14.1) | 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 |
|