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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 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.
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%
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03970343
The ClinicalTrials.gov registry entry for NCT03970343 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 620 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower). The listed sponsor is Impulse Dynamics, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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