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NCT05064709 · ClinicalTrials.gov registry record · NA
Assessment of CCM in HF With Higher Ejection Fraction
A NA study of Heart Failure and Heart Failure With Preserved Ejection Fraction, sponsored by Impulse Dynamics.
- Recruiting
- Registry status
- NA
- Development phase
- 1,500
- Enrollment target
- 20
- Study locations
NCT05064709: Recruiting NA study of Heart Failure and Heart Failure With Preserved Ejection Fraction, sponsored by Impulse Dynamics.
NCT05064709 is a NA study of Heart Failure and Heart Failure With Preserved Ejection Fraction that is actively recruiting participants, run by Impulse Dynamics. The registered enrollment target is 1,500 participants, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064709, a NA study of Heart Failure and Heart Failure With Preserved Ejection Fraction, is actively recruiting participants, sponsored by Impulse Dynamics.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,500 participants
- Enrollment target
- 20
- Study locations
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%.
Primary Outcome
Demonstrate that CCM therapy improves functional capacity in subjects with symptomatic heart failure with LVEF ≥40% and ≤70%. Compare the changes in functional capacity, as measured by the 6-minute walk distance (6MWD), from baseline to 6-months following the randomization date between the two study groups.
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 |
What NCT05064709 shows while recruiting
NCT05064709 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower).
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.
NCT05064709 names 20 study sites across 3 states, led by California, Arizona, Alabama.
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.
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).
Who is sponsoring clinical trial NCT05064709?
This trial is sponsored by Impulse Dynamics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT05064709's enrollment target sits among peer trials
1,500 54th of 397 higher than 340 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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