Aortic InsufficiencyNCT01732835
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
A study testing HAART 300 Annuloplasty Device in people with Aortic Insufficiency, run by Biostable Science & Engineering at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Insufficiency
- 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
- 68 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2012to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- aortic valve insufficiency
- aortic root pathology
- pathology of the ascending aorta
Show all 10Show fewer
- patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass
- 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)
Who cannot join
- The subject has pre-existing valve prosthesis in the aortic position
- The subject's aortic valve morphology is not tri-leaflet
- The subject has active endocarditis
- Heavily calcified valves
- The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
- Leukopenia
Show all 22Show fewer
- 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
- Low Ejection Fraction (EF) EF < 35%
- Life expectancy < 1 year
- 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
- Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
- Myocardial Infarction (MI) within one month of trial inclusion
- The subject has a known intolerance to titanium or polyester
- The subject has documented unstable or > 2 vessel coronary disease
- The subject requires additional valve replacement or valve repair
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
German Heart Center
Berlin, 80636
Uniklinik Köln
Cologne, 50937
Klinik für Herz und Gefässchirurgie
Freiburg im Breisgau, 79106
Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, 20246
Hannover Medical School (MHH)
Hanover, 30625
Munchen Heart Center
München
Klinikum Nürnberg Süd
Nuremberg, 90471
About this study
Official title: The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve
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.
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.
- Conditions
- Aortic Insufficiency
- Being tested
- HAART 300 Annuloplasty Device
- Keywords
- Aortic Insufficiency (AI) Aortic Regurgitation (AR)
- 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 HAART 300 Annuloplasty 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: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
Measured: 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+)
Measured: 6 months
Secondary outcomes (26)
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.
Measured: 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
Measured: 6 months
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
Measured: 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+)
Measured: 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
Measured: 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
Measured: 2 years
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 6 months
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 2 years
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 6 months
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 2 years
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LVEF - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Measured: Baseline and 6 months
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionNov 2015
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.
- Other trials for Aortic InsufficiencyStudies 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biostable Science & Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominico Mazzitelli, MD, Principal investigator, Munchen Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732835
- Sponsor's protocol ID
- TP-01-022
- Status last verified
- Jan 2017
- First submitted
- 20 Nov 2012
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve
- ClinicalTrials.gov ID
- NCT01732835
- Acronym / sponsor ID
- TP-01-022
- Conditions
- Aortic Insufficiency
- Keywords
- Aortic Insufficiency (AI) Aortic Regurgitation (AR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Biostable Science & EngineeringIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 31 Jan 2017
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 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.
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.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- The subject has pre-existing valve prosthesis in the aortic position
- The subject's aortic valve morphology is not tri-leaflet
- The subject has active endocarditis
- Heavily calcified valves
- The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
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 HAART 300 Annuloplasty Device for aortic valve repair | Device | HAART 300 Annuloplasty Device |
Primary outcome
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
Time frame: 6 months
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Time frame: 6 months
Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
26 secondary outcomes
Implant Procedure Success
Time frame: discharge or 14 days postprocedure, whichever comes first
Actuarial Freedom From Clinical Cardiovascular Events
Time frame: 6 months
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
Time frame: 2 years
Aortic Insufficiency (AI) at 2 Years
Time frame: 2 years
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months
Time frame: 6 months
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years
Time frame: 2 years
Peak Gradient - Change From Baseline
Time frame: Baseline and 6 months
Peak Gradient - Change From Baseline
Time frame: Baseline and 2 years
Mean Gradient - Change From Baseline
Time frame: Baseline and 6 months
Mean Gradient - Change From Baseline
Time frame: Baseline and 2 years
LV Mass - Change From Baseline
Time frame: Baseline and 6 months
LV Mass - Change From Baseline
Time frame: Baseline and 2 years
LVID Diastole - Change From Baseline
Time frame: Baseline and 6 months
LVID Diastole - Change From Baseline
Time frame: Baseline and 2 years
LVID Systole - Change From Baseline
Time frame: Baseline and 6 months
LVID Systole - Change From Baseline
Time frame: Baseline and 2 years
LV Diastolic Volume - Change From Baseline
Time frame: Baseline and 6 months
LV Diastolic Volume - Change From Baseline
Time frame: Baseline and 2 years
LV Systolic Volume - Change From Baseline
Time frame: Baseline and 6 months
LV Systolic Volume - Change From Baseline
Time frame: Baseline and 2 years
LVEF - Change From Baseline
Time frame: Baseline and 6 months
LVEF - Change From Baseline
Time frame: Baseline and 2 years
Cardiac Output - Change From Baseline
Time frame: Baseline and 6 months
Cardiac Output - Change From Baseline
Time frame: Baseline and 2 years
Cardiac Index - Change From Baseline
Time frame: Baseline and 6 months
Cardiac Index - Change From Baseline
Time frame: Baseline and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dominico Mazzitelli, MD principal investigator
Munchen Heart Center
8 sites in 2 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 Insufficiency, run by Biostable Science & Engineering at 8 sites in 2 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 22 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, 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 31 Jan 2017). 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: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2017.