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NCT06526195 · ClinicalTrials.gov registry record · NA
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
A NA study of Heart Failure and Cardiovascular Diseases, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 850
- Enrollment target
- 20
- Study locations
NCT06526195: Recruiting NA study of Heart Failure and Cardiovascular Diseases, sponsored by Abbott Medical Devices.
NCT06526195 is a NA study of Heart Failure and Cardiovascular Diseases that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 850 participants, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06526195, a NA study of Heart Failure and Cardiovascular Diseases, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 850 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
Primary Outcome
The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.
Conditions Studied
Interventions
- DEVICE CardioMEMS HF System
- DEVICE HeartMate 3 Left Ventricular Assist System
- OTHER Guideline Medical Directed Therapy
Study Locations (20)
Georgia
- Piedmont Heart Institute - Atlanta
- Piedmont Augusta Hospital - Augusta
- WellStar Kennestone Hospital - Marietta
California
- Sutter Medical Center - Sacramento
- University of California at San Francisco - San Francisco
Florida
- Shands at the University of Florida - Gainesville
- Cleveland Clinic Florida - Weston
Kentucky
- University of Kentucky - Lexington
- Norton Hospital - Louisville
Michigan
- Henry Ford Hospital - Detroit
- Spectrum Health Butterworth Hospital - Grand Rapids
Arizona
- Banner-University Medical Center Phoenix - Phoenix
Arkansas
- Baptist Health Medical Center - Little Rock
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2024-12-13 |
| Est. Completion | 2032-09 |
| Phase | NA |
What NCT06526195 shows while recruiting
NCT06526195 is an interventional study that assigns participants to a tested intervention. The registered 850 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 (58% lower).
The record links to 4 conditions, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which CardioMEMS HF System is the first listed.
NCT06526195 names 20 study sites across 14 states, led by Georgia, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06526195 about?
NCT06526195 is a clinical study titled "Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure". The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
What is the current status of trial NCT06526195?
This trial is currently recruiting. It is a NA study. The enrollment target is 850 participants. The study started on 2024-12-13. Estimated completion is 2032-09.
What conditions does trial NCT06526195 study?
This clinical trial studies the following conditions: Heart Failure, Cardiovascular Diseases, Heart Diseases, Pulmonary Hypertension.
What interventions are being tested in trial NCT06526195?
The interventions under investigation include: CardioMEMS HF System (DEVICE), HeartMate 3 Left Ventricular Assist System (DEVICE), Guideline Medical Directed Therapy (OTHER).
Who is sponsoring clinical trial NCT06526195?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06526195 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. 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 NCT06526195's enrollment target sits among peer trials
850 76th of 397 higher than 322 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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