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New treatment option for Heart Failure
Official title BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
ClinicalTrials.gov ID: NCT06989580
What this study is testing
- What it's testing
- [Plain language]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death rates.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment)
- At least ONE of the following: At least one documented admission with a primary diagnosis of worsening heart failure within last 12 months prior to...
- Ability to understand the nature of the study
- Willingness to provide written informed consent
- Ability and willingness to perform follow-up visits at the study site and via phone
You likely can't join if
- Implanted with pacemaker, ICD or CRT device or ICM
- Class I indication for a pacemaker, ICD or CRT according to current guidelines.
- Permanent or long-standing persistent AF
- Stroke, MI or PCI/CABG within 3 months prior to enrollment
- Patient is on chronic renal or peritoneal dialysis
- Patient has complex adult congenital heart disease
See the full eligibility criteria
- Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment)
- At least ONE of the following: At least one documented admission with a primary diagnosis of worsening heart failure within last 12 months prior to enrollment; OR Unscheduled outpatient visit with increase of oral loop...
- Ability to understand the nature of the study
- Willingness to provide written informed consent
- Ability and willingness to perform follow-up visits at the study site and via phone
- Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
- Implanted with pacemaker, ICD or CRT device or ICM
- Class I indication for a pacemaker, ICD or CRT according to current guidelines.
- Permanent or long-standing persistent AF
- Stroke, MI or PCI/CABG within 3 months prior to enrollment
- Patient is on chronic renal or peritoneal dialysis
- Patient has complex adult congenital heart disease
- Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy
- Patient life expectancy is less than 1 year
- Age \<18 years
- Patient is participating in any other device or drug trial that may interfere with the treatment or protocol of this study or may significantly affect the study outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Genk, Belgium
- Munich, Germany
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genk, Belgium; Munich, Germany. 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.