Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT04441203
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2020-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
Sponsor:
Montreal Heart Institute
Organization:
Study Overview
Official Title:
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SELFIe-HF
Brief Summary:
To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.
Detailed Description:
This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group. Patients with at least one hospitalization for HF (≥1) in the previous year (12 months) will be randomized into two groups, regardless of LVEF:
Usual care with the specialized multidisciplinary HF clinic team (Non-implanted Control) or Hemodynamic monitoring, less intense HF clinic follow-up, and remote follow-up by a nurse clinician and patient empowerment with access to the PAP data (CardioMEMS group).
Primary and secondary endpoints will be compared between groups after 12 months of follow-up and within groups comparing baseline parameters with 12 month follow-up measurements.
Usual care with the specialized multidisciplinary HF clinic team (Non-implanted Control) or Hemodynamic monitoring, less intense HF clinic follow-up, and remote follow-up by a nurse clinician and patient empowerment with access to the PAP data (CardioMEMS group).
Primary and secondary endpoints will be compared between groups after 12 months of follow-up and within groups comparing baseline parameters with 12 month follow-up measurements.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: