BridgeMD
New treatment option for Heart Failure
Official title Heart Failure Management for Patient With CIED Remotely Monitored
ClinicalTrials.gov ID: NCT07247032
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patient aged 18-85
- Patient diagnosed with a New York Heart Association (NYHA) class II or III
- Patients with left ventricular ejection fraction ≼ 40 %
- Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and...
- Non-activation of others HF multisensor algorithms
You likely can't join if
- Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
- Patients with a life expectancy of less than 12 months
- Patients enrolled in concurrent clinical studies
- Patients with a history of non-compliance with medical care or inability to comply with the study protocol
- Patients already receiving remote monitoring for heart failure
- Pregnant or breastfeeding women
See the full eligibility criteria
- Patient aged 18-85
- Patient diagnosed with a New York Heart Association (NYHA) class II or III
- Patients with left ventricular ejection fraction ≼ 40 %
- Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic)
- Non-activation of others HF multisensor algorithms
- Patient remote monitored on Implicity CIED platform
- Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring
- Patient is willing to be remotely monitored for heart failure
- HF treated according to European Society of Cardiology (ESC) guidelines
- Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
- Patients with a life expectancy of less than 12 months
- Patients enrolled in concurrent clinical studies
- Patients with a history of non-compliance with medical care or inability to comply with the study protocol
- Patients already receiving remote monitoring for heart failure
- Pregnant or breastfeeding women
- people under legal protection
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.