Aortic RegurgitationNCT01400841
HAART Model 300 Annuloplasty Ring
A study testing HAART 300 Annuloplasty Device in people with Aortic Regurgitation, run by Biostable Science & Engineering at 4 sites in 3 countries.
Trial summary
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Regurgitation
- What is being tested?
- HAART 300 Annuloplasty Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 50 years old or older
- The subject has a tricuspid aortic valve morphology
- Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis
- Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets
- Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms
- Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease
Show all 10Show fewer
- Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
- The subject has signed the written informed consent
- The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
- The subject is New York Hospital Association (NYHA) class II or III
Who cannot join
- The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position
- The subject requires an additional valve replacement
- The subject's aortic valve morphology is not tricuspid
- The subject has active endocarditis
- Heavily calcified valves
- Valvular retraction with severely reduced mobility
Show all 31Show fewer
- The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
- The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device
- Leukopenia
- Acute anemia (Hb < 9mg%)
- Platelet count <100,000 cell/mm3
- Need for emergency surgery for any reason
- History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
- Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
- Subjects in whom transesophageal echocardiography (TEE) is contraindicated
- Non elective presentation
- Low Ejection Fraction (EF) EF < 40%
- Life expectancy < 1 year
- Rheumatic disease
- The subject has severe leaflet fenestration or leaflets damaged by endocarditis
- The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
- The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
- The subject is pregnant or lactating
- This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up
- The subject has not signed and dated the study informed consent
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Myocardial infarction (MI) within one month of trial inclusion
- Have a known intolerance to titanium or polyester
- Sole therapy for correction for patients with aortic root aneurysm
- Subjects requiring simultaneous cardiac procedures
- The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) > 50%
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
German Heart Institute
Berlin, 13353
German Heart Center Munich
Munich, 80636
About this study
Official title: A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D Intra-annular Mounting Frame
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame
Read the detailed description
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. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.
- Conditions
- Aortic Regurgitation
- Being tested
- HAART 300 Annuloplasty Device
- Keywords
- Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAART 300 Annuloplasty DeviceDevice
Implantation of device for aortic valve repair
| Study group | Role | What they receive |
|---|---|---|
| HAART 300 Annuloplasty Device | Experimental | Implantation of HAART 300 Annuloplasty Device for aortic valve repair Receives: Device: HAART 300 Annuloplasty Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome Measure: Event-free Survival
Event-free survival is defined as survival free from device-related death
Measured: 1 month postprocedure
Primary Safety Outcome Measure: Event-free Survival
Event-free survival is defined as survival free from device-related death
Measured: 2 years postprocedure (extended follow-up)
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Measured: 6 months postprocedure
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Measured: 2 years postprocedure (extended follow-up)
Secondary outcomes (27)
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
- Paravalvular leak > +2 or requiring intervention
- 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.
Measured: discharge or 14 days postprocedure, whichever comes first
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
- Paravalvular leak > +2 or requiring intervention
- 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.
Measured: 2 years postprocedure (extended follow-up)
Actuarial Freedom From Clinical Cardiovascular Events
Freedom from specified clinical cardiovascular events 1 month 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 1 month
Measured: 1 month postprocedure
Actuarial Freedom From Clinical Cardiovascular Events
Freedom from specified clinical cardiovascular events 2 years 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 2 years
Measured: 2 years postprocedure
Event-free Survival
Event-free survival is defined as survival free from device-related death
Measured: 6 months postprocedure
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
Measured: 6 months postprocedure
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
Measured: 2 years postprocedure (extended follow-up)
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline, 6 months postprocedure
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline, 2 years postprocedure (extended follow-up)
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline, 6 months postprocedure
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline, 2 years postprocedure (extended follow-up)
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Measured: Baseline, 6 months postprocedure
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Measured: Baseline, 2 years postprocedure (extended follow-up)
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Measured: Baseline, 6 months postprocedure
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Measured: Baseline, 2 years postprocedure (extended follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biostable Science & Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christof Stamm, M.D., Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400841
- Sponsor's protocol ID
- BSE 300
- Other IDs
- TP-01-013, TP-01-023
- Status last verified
- Nov 2016
- First submitted
- 21 Jul 2011
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.
PubMed 26156945Mazzitelli D, Stamm C, Rankin JS, Pfeiffer S, Fischlein T, Pirk J, Choi YH, Detter C, Kroll J, Beyersdorf F, Shrestha M, Schreiber C, Lange R. Leaflet reconstructive techniques for aortic valve repair. Ann Thorac Surg. 2014 Dec;98(6):2053-60. doi: 10.1016/j.athoracsur.2014.06.052. Epub 2014 Dec 1.
PubMed 25468084Mazzitelli D, Stamm C, Rankin JS, Nobauer C, Pirk J, Meuris B, Crooke PS, Wagner A, Beavan LA, Griffin CD, Powers D, Nasseri B, Schreiber C, Hetzer R, Lange R. Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial. J Thorac Cardiovasc Surg. 2014 Jul;148(1):168-75. doi: 10.1016/j.jtcvs.2013.08.031. Epub 2013 Oct 8.
PubMed 24113022Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Dorfmeister M, Crooke PS, Wagner A, Schreiber C, Lange R. Early results of a novel technique for ring-reinforced aortic valve and root restoration. Eur J Cardiothorac Surg. 2014 Mar;45(3):426-30. doi: 10.1093/ejcts/ezt407. Epub 2013 Aug 19.
PubMed 23959743
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D Intra-annular Mounting Frame
- ClinicalTrials.gov ID
- NCT01400841
- Acronym / sponsor ID
- BSE 300
- Conditions
- Aortic Regurgitation
- Keywords
- Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Biostable Science & EngineeringIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 22 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame
Detailed description
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. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAART 300 Annuloplasty Device | Experimental | Device: HAART 300 Annuloplasty DeviceImplantation of HAART 300 Annuloplasty Device for aortic valve repair |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject is 50 years old or older
- The subject has a tricuspid aortic valve morphology
- Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis
- Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets
- Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms
Key exclusion criteria (31 listed)
- The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position
- The subject requires an additional valve replacement
- The subject's aortic valve morphology is not tricuspid
- The subject has active endocarditis
- Heavily calcified valves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAART 300 Annuloplasty DeviceImplantation of device for aortic valve repair | Device | HAART 300 Annuloplasty Device |
Primary outcome
Primary Safety Outcome Measure: Event-free Survival
Time frame: 1 month postprocedure
Event-free survival is defined as survival free from device-related death
Primary Safety Outcome Measure: Event-free Survival
Time frame: 2 years postprocedure (extended follow-up)
Event-free survival is defined as survival free from device-related death
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
Time frame: 6 months postprocedure
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
Time frame: 2 years postprocedure (extended follow-up)
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
27 secondary outcomes
Implant Procedure Success
Time frame: discharge or 14 days postprocedure, whichever comes first
Implant Procedure Success
Time frame: 2 years postprocedure (extended follow-up)
Actuarial Freedom From Clinical Cardiovascular Events
Time frame: 1 month postprocedure
Actuarial Freedom From Clinical Cardiovascular Events
Time frame: 2 years postprocedure
Event-free Survival
Time frame: 6 months postprocedure
New York Heart Association (NYHA) Functional Capacity Classification
Time frame: 6 months postprocedure
New York Heart Association (NYHA) Functional Capacity Classification
Time frame: 2 years postprocedure (extended follow-up)
Peak Gradient - Change From Baseline
Time frame: Baseline, 6 months postprocedure
Peak Gradient - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Mean Gradient - Change From Baseline
Time frame: Baseline, 6 months postprocedure
Mean Gradient - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
LV Mass - Change From Baseline
Time frame: Baseline, 6 months postprocedure
LV Mass - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
LVID Diastole - Change From Baseline
Time frame: Baseline, 6 months postprocedure
LVID Diastole - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
LVID Systole - Change From Baseline
Time frame: Baseline, 6 months postprocedure
LVID Systole - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
LV Diastolic Volume - Change From Baseline
Time frame: Baseline, 6 months postprocedure
LV Diastolic Volume - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
LV Systolic Volume - Change From Baseline
Time frame: Baseline, 6 months postprocedure
LV Systolic Volume - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
LVEF - Change From Baseline
Time frame: Baseline, 6 months postprocedure
LVEF - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Cardiac Output - Change From Baseline
Time frame: Baseline, 6 months postprocedure
Cardiac Output - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Cardiac Index - Change From Baseline
Time frame: Baseline, 6 months postprocedure
Cardiac Index - Change From Baseline
Time frame: Baseline, 2 years postprocedure (extended follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26156945Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.
- Derived from this study: PubMed 25468084Mazzitelli D, Stamm C, Rankin JS, Pfeiffer S, Fischlein T, Pirk J, Choi YH, Detter C, Kroll J, Beyersdorf F, Shrestha M, Schreiber C, Lange R. Leaflet reconstructive techniques for aortic valve repair. Ann Thorac Surg. 2014 Dec;98(6):2053-60. doi: 10.1016/j.athoracsur.2014.06.052. Epub 2014 Dec 1.
- Derived from this study: PubMed 24113022Mazzitelli D, Stamm C, Rankin JS, Nobauer C, Pirk J, Meuris B, Crooke PS, Wagner A, Beavan LA, Griffin CD, Powers D, Nasseri B, Schreiber C, Hetzer R, Lange R. Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial. J Thorac Cardiovasc Surg. 2014 Jul;148(1):168-75. doi: 10.1016/j.jtcvs.2013.08.031. Epub 2013 Oct 8.
- Derived from this study: PubMed 23959743Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Dorfmeister M, Crooke PS, Wagner A, Schreiber C, Lange R. Early results of a novel technique for ring-reinforced aortic valve and root restoration. Eur J Cardiothorac Surg. 2014 Mar;45(3):426-30. doi: 10.1093/ejcts/ezt407. Epub 2013 Aug 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christof Stamm, M.D. principal investigator
German Heart Institute
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAART 300 Annuloplasty Device in people with Aortic Regurgitation, run by Biostable Science & Engineering at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Belgium, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome Measure: Event-free Survival (time frame: 1 month postprocedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400841, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.