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

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT03970343
• Lead Sponsor: Impulse Dynamics

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 Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Study Start: 2020-01-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

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, per site assessment)
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 medical therapy

Exclusion Criteria

1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
3. Myocardial infarction within 90 days prior to implant
4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
5. Prior heart transplant or ventricular assist device
6. Mechanical tricuspid valve
7. 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
8. Participating in a cardiac investigational study at the same time
9. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of procedure and device-related complications	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	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
Procedure related complications	30-days	Procedure related complications through the end of 30 days following the index procedure

Secondary Outcome Measures

Name	Time	Method
Cardiovascular hospitalizations	2 years	Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation

Trial Locations

Locations (91)

CardioVascular Associates of Mesa (CVAM); 🇺🇸 Mesa, Arizona, United States

Chan Heart Rhythm Institute (CHRI); 🇺🇸 Mesa, Arizona, United States

Southwest Cardiovascular Associates; 🇺🇸 Mesa, Arizona, United States

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Cardiovascular Society of Arizona; 🇺🇸 Phoenix, Arizona, United States

Arizona Cardiovascular Research Center; 🇺🇸 Phoenix, Arizona, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

Pima Heart and Vascular Research Center; 🇺🇸 Tucson, Arizona, United States

University of AZ - Sarver Heart Center; 🇺🇸 Tucson, Arizona, United States

Cardiovascular Institute of San Diego; 🇺🇸 Chula Vista, California, United States

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