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出境医 / 临床实验 / Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS)

Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS)

Study Description
Brief Summary:
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%

Condition or disease Intervention/treatment
Heart Failure Device: OPTIMIZER Smart

Detailed Description:
The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 620 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Incidence of procedure and device-related complications [ Time Frame: 1 year ]
    Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year)

  2. All-cause mortality [ Time Frame: 3 years ]
    Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 23, 2019
First Posted Date May 31, 2019
Last Update Posted Date June 3, 2021
Actual Study Start Date January 21, 2020
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2019)
  • Incidence of procedure and device-related complications [ Time Frame: 1 year ]
    Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year)
  • All-cause mortality [ Time Frame: 3 years ]
    Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant
Original Primary Outcome Measures
 (submitted: May 30, 2019)
  • Safety Objectives [ Time Frame: 30 days post-implant ]
    Assessing the rate of procedure-related complications
  • Safety Objectives [ Time Frame: 1 year post-implant ]
    Assessing the rate of device-related complications
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Official Title A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
Brief Summary The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
Detailed Description The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.
Condition Heart Failure
Intervention Device: OPTIMIZER Smart

Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components:

  1. Programmable Optimizer Smart Implantable Pulse Generator (IPG)
  2. OMNI Smart Programmer
  3. Optimizer Smart Charger

Two commercially available intravascular leads complete the system.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2019) 		620
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient provides written authorization and/or consent per institution and geographical requirements
  2. Male or non-pregnant female, aged 18 or older
  3. Left ventricular ejection fraction of 25-45% (inclusive)
  4. NYHA Class III heart failure symptoms
  5. Stated willingness to comply with all study procedures and availability for the duration of the study
  6. Patient has been treated with guideline-directed heart failure therapies with stable doses for at least 30 days prior to implant

Exclusion Criteria:

  1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry disease, cardiac tumor)
  2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days prior to implant
  3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant, including continuous IV inotrope therapy
  4. Myocardial infarction within 90 days prior to implant
  5. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days prior to implant
  6. Persistent (lasting more than 7 days) or permanent lasting more than 1 year) atrial fibrillation or atrial flutter or cardioverted within 30 days prior to implant
  7. Prior heart transplant or ventricular assist device
  8. Mechanical tricuspid valve
  9. PR interval greater than 375ms
  10. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
  11. Currently on dialysis
  12. Currently undergoing treatment for cancer
  13. Participating in another cardiac investigational study at the same time
  14. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.
  15. Other criteria that precludes Optimizer implantation and/or CCM therapy, as determined by Investigator
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Angela Stagg 845-359-2389 ext 206 angelas@impulse-dynamics.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03970343
Other Study ID Numbers CA_CP_307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Impulse Dynamics
Study Sponsor Impulse Dynamics
Collaborators Not Provided
Investigators
Study Director: Rami Kahwash, MD The Ohio State University Wexner Medical Center
Study Director: Raul Weiss, MD The Ohio State University Wexner Medical Center
PRS Account Impulse Dynamics
Verification Date June 2021

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