N/A
N=16
HAART Model 300 Annuloplasty Ring
Aortic Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT01400841 ↗Enrolled (actual)
16
Serious AEs
50.0%
Results posted
Nov 2016
Primary outcome: Primary: Primary Safety Outcome Measure: Event-free Survival — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HAART 300 Annuloplasty Device (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Biostable Science & Engineering
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Outcome Measure: Event-free Survival |
100 | — |
| PRIMARY Primary Safety Outcome Measure: Event-free Survival |
100 | — |
| PRIMARY Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure |
2; 9; 3; 1; 0 | — |
| PRIMARY Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure |
2; 7; 2; 0; 0 | — |
| SECONDARY Implant Procedure Success |
87.5 | — |
| SECONDARY Implant Procedure Success |
87.5 | — |
| SECONDARY Actuarial Freedom From Clinical Cardiovascular Events |
81.5 | — |
| SECONDARY Actuarial Freedom From Clinical Cardiovascular Events |
81.5 | — |
| SECONDARY Event-free Survival |
100 | — |
| SECONDARY New York Heart Association (NYHA) Functional Capacity Classification |
8; 3; 0; 0 | — |
| SECONDARY New York Heart Association (NYHA) Functional Capacity Classification |
8; 3; 0; 0 | — |
| SECONDARY Peak Gradient - Change From Baseline |
10.1 | — |
| SECONDARY Peak Gradient - Change From Baseline |
10.1 | — |
| SECONDARY Mean Gradient - Change From Baseline |
4.8 | — |
| SECONDARY Mean Gradient - Change From Baseline |
4.8 | — |
| SECONDARY LV Mass - Change From Baseline |
-23.3 | — |
| SECONDARY LV Mass - Change From Baseline |
-23.3 | — |
| SECONDARY LVID Diastole - Change From Baseline |
-0.33 | — |
| SECONDARY LVID Diastole - Change From Baseline |
-0.33 | — |
| SECONDARY LVID Systole - Change From Baseline |
0.03 | — |
| SECONDARY LVID Systole - Change From Baseline |
0.03 | — |
| SECONDARY LV Diastolic Volume - Change From Baseline |
-75.4 | — |
| SECONDARY LV Diastolic Volume - Change From Baseline |
-75.4 | — |
| SECONDARY LV Systolic Volume - Change From Baseline |
-48.4 | — |
| SECONDARY LV Systolic Volume - Change From Baseline |
-48.4 | — |
| SECONDARY LVEF - Change From Baseline |
12.20 | — |
| SECONDARY LVEF - Change From Baseline |
12.20 | — |
| SECONDARY Cardiac Output - Change From Baseline |
-0.36 | — |
| SECONDARY Cardiac Output - Change From Baseline |
-0.36 | — |
| SECONDARY Cardiac Index - Change From Baseline |
-0.22 | — |
| SECONDARY Cardiac Index - Change From Baseline |
-0.22 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
- 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 50%
Data sourced from ClinicalTrials.gov (NCT01400841). 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.