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NCT03970343 · ClinicalTrials.gov registry record
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
A clinical trial of Heart Failure, sponsored by Impulse Dynamics.
- Active
- Registry status
- 620
- Enrollment target
- 20
- Study locations
NCT03970343: Active study of Heart Failure, sponsored by Impulse Dynamics.
NCT03970343 is a study of Heart Failure that is active but no longer recruiting, run by Impulse Dynamics. The registered enrollment target is 620 participants, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970343, a study of Heart Failure, is active but no longer recruiting, sponsored by Impulse Dynamics.
- ACTIVE NOT RECRUITING
- Registry status
- 620 participants
- Enrollment target
- 20
- Study locations
Study 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%
Primary Outcome
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)
Conditions Studied
Interventions
- DEVICE OPTIMIZER Smart System
Study Locations (20)
Arizona
- CardioVascular Associates of Mesa (CVAM) - Mesa
- Chan Heart Rhythm Institute (CHRI) - Mesa
- Southwest Cardiovascular Associates - Mesa
- Banner University Medical Center - Phoenix
- Cardiovascular Society of Arizona - Phoenix
- Arizona Cardiovascular Research Center - Phoenix
- Honor Health - Scottsdale
- Pima Heart and Vascular Research Center - Tucson
- University of AZ - Sarver Heart Center - Tucson
California
- Cardiovascular Institute of San Diego - Chula Vista
- NorthBay Health, Heart and Vascular - Fairfield
- Mid Valley Cardiology - Fresno - Fresno
- South Orange County Cardiology Group - Laguna Hills
- University of Southern California - Keck School of Medicine - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Valley Clinical Trials - Northridge
- Valley Clinical Trials - Pasadena
- Torrance Memorial Medical Center - Torrance
Colorado
- Aurora Denver Cardiology Associates - Aurora
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2028-07 |
What the registry record for NCT03970343 still lists
NCT03970343 is an observational study that tracks outcomes without assigning an intervention. The registered 620 participants enrollment target is mid-sized for trials with a published cap, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which OPTIMIZER Smart System is the first listed.
NCT03970343 names 20 study sites across 4 states, led by Arizona, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03970343 about?
NCT03970343 is a clinical study titled "Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy". 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-...
What is the current status of trial NCT03970343?
This trial is currently active not recruiting. The enrollment target is 620 participants. The study started on 2020-01-21. Estimated completion is 2028-07.
What conditions does trial NCT03970343 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT03970343?
The interventions under investigation include: OPTIMIZER Smart System (DEVICE).
Who is sponsoring clinical trial NCT03970343?
This trial is sponsored by Impulse Dynamics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03970343 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03970343's enrollment target sits among peer trials
620 89th of 397 higher than 308 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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