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New treatment option for Idiopathic Cardiomyopathy
Official title Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
ClinicalTrials.gov ID: NCT06920030
What this study is testing
- What it's testing
- Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction \>40% and \<50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management. The device can be implanted without the need for open-heart surgery.
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 75
You may be able to join if
- Idiopathic Dilated Cardiomyopathy with HFrEF:
- Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III -...
- Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab. Non-Ischaemic Cardiomyopathy with HFmrEF:
- Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III...
- Patients who have a baseline left ventricular ejection fraction of \>40% and \<50% assessed by corelab. for all Patients:
You likely can't join if
- Patients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease...
- Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Patients with an indication for a CRT system according to current guidelines.
- Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before screening.
- Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
- Patients with hemoglobin blood level \< 12 g/dl in male and \< 10 g/dl in female patients.
See the full eligibility criteria
Who can join
- Idiopathic Dilated Cardiomyopathy with HFrEF:
- Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV).
- Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab. Non-Ischaemic Cardiomyopathy with HFmrEF:
- Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III - IV).
- Patients who have a baseline left ventricular ejection fraction of \>40% and \<50% assessed by corelab. for all Patients:
- Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
- Female and male patients aged ≥18 years - 75 years.
- Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial and about the intended treatment period of 6 months which is...
- Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the...
- Patients with HFrEF: \- Angiotensin-converting enzyme inhibitor (ACE-I) or \- Angiotensin receptor-neprilysin inhibitor (ARNI) \- Beta-blocker \- Mineralocorticoid receptor antagonist (MRA) \-...
- Patients with HFmrEF - Diuretics (if symptomatic)
- Dapagliflozin/Empagliflozin inhibitor (SGLT2i)
- Patients who can perform a non-assisted 6-minute walk test.
- Patients must have a body mass index within the range of 20 - 36 kg/m².
- Informed consent in writing obtained from patient.
What rules you out
- Patients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for...
- Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Patients with an indication for a CRT system according to current guidelines.
- Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before screening.
- Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
- Patients with hemoglobin blood level \< 12 g/dl in male and \< 10 g/dl in female patients.
- Patients with primary pulmonary hypertension
- Patients who have genetic connective tissue disease (for example Marfan syndrome).
- Patients with a prosthetic tricuspid valve.
- Patients in whom access for implantation of the leads cannot be obtained (i.e. known venous occlusion, post radiation therapy).
- Patient with other features (i.e. thorax deformity) that in the eyes of the investigator make the straightforward placement of the device seem unlikely.
- Patients with a pacemaker, an ICD system, a CRT system or with a CCM system.
- Current pregnancy or
- Breastfeeding/lactating women
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (e.g. intrauterine device, oral contraceptives, barrier...
- Patients whose exercise tolerance is limited by a condition other than heart failure (e.g. chronic obstructive pulmonary disease, peripheral vascular 16. Patients on immunosuppressive therapy. 17.Patie nts with present...
- Areas with strong magnetic fields
- Areas with strong external electrical influences
- Areas with a warning notice "Access prohibited for pacemaker patients" or similar.
- Areas with high temperatures
The study team makes the final eligibility decision.
Where it's taking place
- Banja Luka, Republic of Srbska, Bosnia and Herzegovina
- Belgrade, Serbia
- Kragujevac, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banja Luka, Republic of Srbska, Bosnia and Herzegovina; Belgrade, Serbia; Kragujevac, Serbia. 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.