435 Studies Now Enrolling
Medtronic ALgorithm using LINQ Sensors for EValuation And TreatmEnt of Heart Failure (ALLEVIATE-HF)
ALLEVIATE-HF: Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
| Sponsor: | Medtronic |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAT3033 |
| U.S. Govt. ID: | NCT04452149 |
| Contact: | Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
Additional Study Information:
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will utilize the market-released Reveal LINQ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. The study will enroll up to 300 subjects at up to 30 sites in the US and will characterize the safety of the patient management pathway. Subjects will be followed for a minimum of 7 months, and until study closure.
Do You Qualify?
| Are you 18 years of age or older? | Yes | No |
| Have you been diagnosed with Heart Failure? | Yes | No |
| Have you been hospitalized within the last 12 months for Heart Failure or have received inotropic therapy? | Yes | No |
| Have you been implanted with a cardiovascular electronic device? (CRT, ICD, or CardioMEMS) | Yes | No |