Mitral Valve Disease Clinical Trial
Official title:
HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
NCT number | NCT02097420 |
Other study ID # | CL06404 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2015 |
Est. completion date | July 2023 |
Verified date | May 2024 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.
Status | Completed |
Enrollment | 23 |
Est. completion date | July 2023 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 5 Years |
Eligibility | IDE Cohort - Inclusion Criteria: 1. Subject requires mitral valve replacement.* 2. Subject's legally authorized representative gives written consent to participate in the clinical study. 3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. - Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria. Exclusion Criteria: 1. 1. Subject is > 5 years of age. 2. Subject has a contraindication to anticoagulant/antiplatelet medication. 3. Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.* 4. Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve. 5. Subject has active endocarditis. 6. Subject has active myocarditis. 7. Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized = 30 days prior to the study procedure. 8. Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized =48 hours prior to the study procedure. 9. Subject has a non-cardiac illness resulting in a life expectancy of < 1 year. 10. Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure. 11. Subject has been previously enrolled and implanted in this study. 12. Subject is participating in another study for an investigational drug and/or device. 13. Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results. - Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study. Continued Access Cohort- Prospective Inclusion Criteria: 1. Subject requires mitral valve replacement.* 2. Subject's legally authorized representative gives written consent to participate in the clinical study. 3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. - Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study. Prospective Exclusion Criteria: 1. Subject is > 5 years of age. 2. Subject has a contraindication to anticoagulant/antiplatelet medication. Retrospective Eligibility Criteria: 1. The subject must have been = 5 years of age at the time of mitral valve replacement with the 15mm MHV. 2. An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. 3. The legally authorized representative signs the study informed consent for this protocol allowing access to all relevant historical medical information and prospective follow-up (if applicable). 4. Either 1. the legally authorized representative and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol from the time of consent going forward. OR 2. the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Children's Hospital of Colorado | Aurora | Colorado |
United States | University of Maryland School of Medicine | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Levine Children's Hospital / Sanger Heart & Vascular Institute | Charlotte | North Carolina |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Texas Children's Hospital | Houston | Texas |
United States | University of Missouri-Kansas City School of Medicine | Kansas City | Missouri |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Children's Hospital Los Angeles (USC) | Los Angeles | California |
United States | Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota |
United States | University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota |
United States | West Virginia University Hospital | Morgantown | West Virginia |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | New York Presbyterian Hospital/Columbia University | New York | New York |
United States | Children's Hospital & Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Maine Medical Center | Portland | Maine |
United States | University of California - Davis Medical Center | Sacramento | California |
United States | University of Utah Hospital | Salt Lake City | Utah |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Sacred Heart Medical Center | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth | The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate.
Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. |
12 months | |
Primary | Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography | Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months | |
Primary | Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography | Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months | |
Primary | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months | |
Primary | Primary Safety Endpoint: Rate of Total Valve-related Adverse Events | Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months | |
Secondary | Percentage Change in Height Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit. | 12 months | |
Secondary | Percentage Change in Weight Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03283722 -
PRESERVE-MITRAL Post-Market Registry
|
||
Not yet recruiting |
NCT06167213 -
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
|
N/A | |
Recruiting |
NCT06001489 -
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
|
N/A | |
Recruiting |
NCT06025149 -
The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
|
||
Completed |
NCT05193760 -
Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
|
||
Completed |
NCT05836558 -
Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?
|
||
Recruiting |
NCT05531253 -
Respired Gases in Patients Post Cardiac Surgery
|
||
Completed |
NCT04045340 -
Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery
|
||
Active, not recruiting |
NCT04950192 -
Philips Intracardiac Echocardiography (ICE) Clinical Registry
|
||
Recruiting |
NCT02925819 -
Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
|
||
Completed |
NCT03438825 -
PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
|
||
Completed |
NCT02000544 -
Clinical Evaluation of a Modular Extracorporeal Circulation Circuit
|
N/A | |
Recruiting |
NCT03574311 -
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
|
Phase 4 | |
Recruiting |
NCT06153563 -
Evaluation of the Elasticity of the Mitral Valve
|
||
Active, not recruiting |
NCT03539458 -
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
|
N/A | |
Recruiting |
NCT05898230 -
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
|
||
Withdrawn |
NCT01849757 -
Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%
|
N/A | |
Active, not recruiting |
NCT04147884 -
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
|
N/A | |
Enrolling by invitation |
NCT04067635 -
Primary Mitral Regurgitation Repair
|
||
Recruiting |
NCT04954404 -
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
|
N/A |