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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 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.
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%.
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The listed sponsor is Impulse Dynamics, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
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