N/A
N=20
HAART 200 Aortic Valve Annuloplasty Trial
Aortic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02071849 ↗Enrolled (actual)
20
Serious AEs
50.0%
Results posted
Mar 2017
Primary outcome: Primary: Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HAART 200 Aortic Valve Annuloplasty Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biostable Science & Engineering
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. |
100 | — |
| PRIMARY Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months |
5; 6; 4; 0; 0 | — |
| SECONDARY Implant Procedure Success |
100 | — |
| SECONDARY Actuarial Freedom From Clinical Cardiovascular Events |
81.2 | — |
| SECONDARY Actuarial Freedom From Clinical Cardiovascular Events |
81.2 | — |
| SECONDARY Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure. |
100 | — |
| SECONDARY Aortic Insufficiency (AI) at 2 Years |
2; 11; 1; 0; 0 | — |
| SECONDARY New York Heart Association (NYHA) Functional Capacity Classification |
15; 0; 0; 0 | — |
| SECONDARY NYHA Functional Capacity Classification |
14; 0; 0; 0 | — |
| SECONDARY Peak Gradient - Change From Baseline |
1.4 | — |
| SECONDARY Peak Gradient - Change From Baseline |
1.4 | — |
| SECONDARY Mean Gradient - Change From Baseline |
2.4 | — |
| SECONDARY Mean Gradient - Change From Baseline |
2.4 | — |
| SECONDARY Left Ventricular (LV) Mass - Change From Baseline |
-53.98 | — |
| SECONDARY LV Mass - Change From Baseline |
-78.84 | — |
| SECONDARY Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline |
-0.306 | — |
| SECONDARY LVID Diastole - Change From Baseline |
-0.455 | — |
| SECONDARY LVID Systole - Change From Baseline |
-0.700 | — |
| SECONDARY LVID Systole - Change From Baseline |
-0.700 | — |
| SECONDARY LV Diastolic Volume - Change From Baseline |
26.9 | — |
| SECONDARY LV Diastolic Volume - Change From Baseline |
26.9 | — |
| SECONDARY LV Systolic Volume - Change From Baseline |
7.9 | — |
| SECONDARY LV Systolic Volume - Change From Baseline |
7.9 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) - Change From Baseline |
4.21 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) - Change From Baseline |
4.21 | — |
| SECONDARY Cardiac Output - Change From Baseline |
-2.145 | — |
| SECONDARY Cardiac Output - Change From Baseline |
-2.145 | — |
| SECONDARY Cardiac Index - Change From Baseline |
-1.09 | — |
| SECONDARY Cardiac Index - Change From Baseline |
-1.09 | — |
Summary
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).
Eligibility Criteria
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:
- Aortic valve insufficiency
- Ascending aortic or aortic root pathology
- Other pathology of the ascending aorta that requires elective aortic replacement
- Associated stable one or two vessel coronary disease requiring concomitant coronary bypass
- Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation
- All bicuspid annular and leaflet configurations will be included
- The subject needs:
- correction of BAV annular dilatation in patients with chronic AI and dilated annulus
- restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions
- stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation
- 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
- All patients will be excluded who require emergency surgery for any reason.
- All the patients who have had a prior heart valve replacement
- The subject's aortic valve morphology is not bicuspid.
- The subject has active endocarditis
- The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
- Heavily calcified BAV valves, calcified aortic roots, or "porcelain aortas"
- Leukopenia with a White Blood Cell (WBC) of less than 3000
- Acute anemia with a Hgb less than 9mg%
- Platelet count less than 100,000 cells/mm3
- History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions
- Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics)
- Subjects in whom transesophageal echocardiography (TEE) is contraindicated
- Low Ejection Fraction (EF) 2 vessel coronary disease
- The subject requires additional valve replacement or valve repair
Data sourced from ClinicalTrials.gov (NCT02071849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.