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Assessment of CCM in HF With Higher Ejection Fraction
NCT05064709 · View on ClinicalTrials.gov ↗
Study Summary
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
Conditions Studied
Interventions
- DEVICE Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
- DEVICE OPTIMIZER™ Smart Mini System
Study Locations (20)
California
- John Muir Health — Concord
- Northbay Heart and Vascular — Fairfield
- University of California San Diego — La Jolla
- USC Keck School of Medicine — Los Angeles
- Cedars Sinai Medical Center — Los Angeles
- Valley Clinical Trials Pasadena — Northridge
- Valley Clinical Trials- Northridge — Northridge
- Sequoia Hospital — Redwood City
- University of California Davis Health — Sacramento
- University of California, San Francisco — San Francisco
Arizona
- CardioVascular Associates of Mesa — Mesa
- Chan Heart Rhythm Institute — Mesa
- Southwest Cardiovascular Associates — Mesa
- Banner Health- Phoenix — Phoenix
- Arizona Heart Rhythm — Phoenix
- Cardiovascular Consultants, Ltd — Phoenix
- HonorHealth — Scottsdale
- Pima Heart and Vascular — Tuscon
Alabama
- Grandview Medical Group Research, LLC — Birmingham
- The University of Alabama at Birmingham — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2022-02-03 |
| Est. Completion | 2029-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05064709
The ClinicalTrials.gov registry entry for NCT05064709 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impulse Dynamics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05064709 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05064709 about?
NCT05064709 is a clinical study titled "Assessment of CCM in HF With Higher Ejection Fraction". The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
What is the current status of trial NCT05064709?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2022-02-03. Estimated completion is 2029-02-01.
What conditions does trial NCT05064709 study?
This clinical trial studies the following conditions: Heart Failure, Heart Failure With Preserved Ejection Fraction, Diastolic Heart Failure, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05064709?
The interventions under investigation include: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System (DEVICE), OPTIMIZER™ Smart Mini System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05064709?
This trial is sponsored by Impulse Dynamics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05064709 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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