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NCT04854200
HVAD(TM) SMART 1.0 Study
trial testing Medtronic HeartWare ™ HVAD™ System in Chronic Heart Failure. Withdrawn.
22 August 2025
Quick facts
| Lead sponsor | Medtronic Cardiac Rhythm and Heart Failure |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 May 2021 |
| Primary completion | 22 August 2025 |
| Estimated completion | 22 August 2025 |
Drugs / interventions tested
- Medtronic HeartWare ™ HVAD™ System
Conditions studied
- Chronic Heart Failure — all drugs for Chronic Heart Failure →
Sponsor
Medtronic Cardiac Rhythm and Heart Failure — full company profile →
Who can join
18 and older, any sex, with Chronic Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of HVAD Smart 1.0 study is to collect HVAD device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse events) to support development of predictive and actionable algorithms. The collected data will be used to characterize HVAD flow waveform and logfile pattern changes that precede a qualifying adverse event, as well as characterize "normal" HVAD flow waveform and logfile patterns (subjects free from any qualifying adverse event, any hospital readmissions related to a SAE, or any parenteral medical therapy for heart failure management (e.g., inotropes, diuretics, etc.) or ultrafiltration in last 30 days). In addition, the study will collect data to evaluate the utility of CareLink in HVAD patients. The study will not involve any investigational testing and the market-released devices will used as per the approved labelling.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04854200
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Heart Failure
Currently open trials in the same condition.
- NCT07265349 — A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure · Phase 1, PHASE2 · recruiting
- NCT07379840 — A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South K · recruiting
- NCT07325942 — Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure · NA · recruiting
- NCT07434193 — Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergo · NA · recruiting
- NCT07405944 — Vericiguat and Reverse Remodeling Indices in Heart Failure · Phase 4 · recruiting
Other Medtronic Cardiac Rhythm and Heart Failure trials
Trials by the same sponsor.
- NCT06910059 — The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Ech · active not recruiting
- NCT06745778 — Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D · recruiting
- NCT06540521 — Bolt CSP-M Holter Study · recruiting
- NCT06038123 — China 3T MRI Study · NA · completed
- NCT06089694 — Crome/Cobalt Respiration Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04854200 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medtronic Cardiac Rhythm and Heart Failure
- Last refreshed: 5 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04854200.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing