Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT07247032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart Failure Management for Patient With CIED Remotely Monitored
Sponsor:
Implicity
Organization:
Study Overview
Official Title:
Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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:
PROACT-HF
Brief Summary:
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart failure. The primary objective is to determine whether SmartSignalHF reduces all-cause mortality and HF hospitalizations at 12 months.
Detailed Description:
SmartSignalHF is a novel digital health solution designed to support clinical decision-making by continuously analyzing Cardiac Implantable Electronic Devices (CIED) and patient data and providing actionable alerts to healthcare teams. By integrating this digital solution into the remote monitoring of HF patients, the study aims to enhance early detection of decompensation events and optimize therapeutic treatments.
Eligible patients implanted with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) and diagnosed with chronic heart failure will be randomized in a 1:1 ratio to either SmartSignalHF remote monitoring solution or standard HF remote monitoring solution.
The primary endpoint is a composite of all-cause mortality and HF hospitalizations within 12 months after randomization. Secondary endpoints include individual components of the primary endpoint, quality-of-life measures, and adherence to guideline-directed medical therapy (GDMT).
Eligible patients implanted with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) and diagnosed with chronic heart failure will be randomized in a 1:1 ratio to either SmartSignalHF remote monitoring solution or standard HF remote monitoring solution.
The primary endpoint is a composite of all-cause mortality and HF hospitalizations within 12 months after randomization. Secondary endpoints include individual components of the primary endpoint, quality-of-life measures, and adherence to guideline-directed medical therapy (GDMT).
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?: