N/A
N=68
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
Aortic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01732835 ↗Enrolled (actual)
68
Serious AEs
46.9%
Results posted
Jan 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 300 Annuloplasty Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biostable Science & Engineering
- Primary completion
- Jun 2014
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 |
11; 21; 7; 2; 0 | — |
| SECONDARY Implant Procedure Success |
95.9 | — |
| SECONDARY Actuarial Freedom From Clinical Cardiovascular Events |
89.6 | — |
| SECONDARY Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure |
97.6 | — |
| SECONDARY Aortic Insufficiency (AI) at 2 Years |
2; 25; 10; 0; 0 | — |
| SECONDARY New York Heart Association (NYHA) Functional Capacity Classification at 6 Months |
30; 13; 0; 0 | — |
| SECONDARY New York Heart Association (NYHA) Functional Capacity Classification at 2 Years |
28; 9; 1; 0 | — |
| SECONDARY Peak Gradient - Change From Baseline |
5.9 | — |
| SECONDARY Peak Gradient - Change From Baseline |
5.9 | — |
| SECONDARY Mean Gradient - Change From Baseline |
3.1 | — |
| SECONDARY Mean Gradient - Change From Baseline |
3.1 | — |
| SECONDARY LV Mass - Change From Baseline |
-27.4 | — |
| SECONDARY LV Mass - Change From Baseline |
-27.4 | — |
| SECONDARY LVID Diastole - Change From Baseline |
-0.22 | — |
| SECONDARY LVID Diastole - Change From Baseline |
-0.22 | — |
| SECONDARY LVID Systole - Change From Baseline |
-0.22 | — |
| SECONDARY LVID Systole - Change From Baseline |
-0.22 | — |
| SECONDARY LV Diastolic Volume - Change From Baseline |
-19.9 | — |
| SECONDARY LV Diastolic Volume - Change From Baseline |
-19.9 | — |
| SECONDARY LV Systolic Volume - Change From Baseline |
-11.1 | — |
| SECONDARY LV Systolic Volume - Change From Baseline |
-11.1 | — |
| SECONDARY LVEF - Change From Baseline |
0.37 | — |
| SECONDARY LVEF - Change From Baseline |
0.37 | — |
| SECONDARY Cardiac Output - Change From Baseline |
-0.50 | — |
| SECONDARY Cardiac Output - Change From Baseline |
-0.50 | — |
| SECONDARY Cardiac Index - Change From Baseline |
-0.26 | — |
| SECONDARY Cardiac Index - Change From Baseline |
-0.26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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)
Exclusion Criteria
- 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
- Acute anemia (Hb 2 vessel coronary disease
- The subject requires additional valve replacement or valve repair
Data sourced from ClinicalTrials.gov (NCT01732835). 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.