Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead

Berlin Heals

Status: Enrolling

Conditions: Idiopathic Cardiomyopathy; Left Ventricular (LV) Systolic Dysfunction

Treatments: Device: Infraclavicular pocket cardiac microcurrent treatment; Device: Subcutaneous cardiac microcurrent treatment; Device: Coronary Sinus cardiac microcurrent treatment

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06920030

C-MIC-III

Details and patient eligibility

About

Patients with idiopathic dilative cardiomyopathy in heart failure (NYHA III - IVa) despite adequate therapy according to treatment guidelines and who have a baseline left ventricular ejection fraction between ≥25% and ≤35% will receive a C-MIC treatment together with optimal medical management. The device will be implanted in 3 different ways without the need to open the chest. Each patient will be assigned to one implantation technique. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the change in left ventricular ejection fraction after 6 months of treatment.

Full description

Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years.

In previous studies, C-MIC was successfully implanted with one of the electrodes (the LV patch electrode) being placed directly on the heart with the necessity to perform a thoracotomy.

In this study the the LV patch electrode will be placed in 2 different locations outside of the ribcage so that there is no need to perform a thoracotomy and in a 3rd group, a coronary sinus electrode is placed instead. In group 1, the LV patch electrode will be placed in a left-thoracic position into a subcutaneous pocket. In group 2, the LV patch electrode will be placed into one subcutaneous, infraclavicular pocket together with the microcurrent device itself. In group 3, the LV patch electrode will be replaced with a coronary sinus electrode that is placed transvenously.

In all the groups, the effect of the microcurrent therapy will be assessed by comparing LV election fraction changes between baseline and after 6 months of microcurrent treatment (primary endpoint).

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV (ambulatory)).
• Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
• Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab echocardiography within 30 days prior to device implantation.
• 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 derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to the study regimen and to return for all followup visits.

Exclusion criteria

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 use of the device or if the therapy with the C-MIC System is not possible or might be associated with unknown risks:

• 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).

• Patients who have other preexisting epicardial leads.

• 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*.

• 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 methods, or other contraception deemed adequate by the investigator) 2 months before and until 1 month after C-MIC therapy. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 2 months before screening.

• Current pregnancy or

• Breastfeeding/lactating women

• Patients whose exercise tolerance is limited by a condition other than heart failure (e.g. chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to participate in a 6-minute walk test.

• Patients on immunosuppressive therapy.

• Patients with present malignancy.

• Patients with an active infection considered by the investigator to be unsafe for the patient's participation in the trial.

• Patients with renal dysfunction (i.e., estimated glomerular filtration rate <45 mL/min /1,73 m²)

• Patients with history or presence of relevant liver diseases or hepatic dysfunction as indicated by abnormal liver function tests at screening and baseline: ALT (SGPT), AST (SGOT), γ-GT, alkaline, phosphatase and serum bilirubin >2 × upper limit of normal (ULN). Increase of these liver enzymes caused by cardiac disorders in the absence of other possible causes of liver damage are not meant by this.

• Patients with a history of drug or alcohol abuse within the 12 months prior to screening.

• Patients who, in the opinion of the Principal Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, psychological illness, and improbability of completing the trial.

• Participation in any study of an investigational device or drug within 90 days prior to planned study.

• Vulnerable Patients (e.g. patients requiring a legal representative, patients kept in detention, any service within the army, and employees of the sponsor or at an investigator site).

• Patients who are not able to avoid the following areas (i.e. due to work):

  • 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Sub-Q implantation

Experimental group

Description:

The LV patch electrode will be positioned in a left-thoracic subcutaneous pocket

Treatment:

Device: Subcutaneous cardiac microcurrent treatment

device-pocket

Experimental group

Description:

The LV patch electrode will be placed in the same pocket as the device itself

Treatment:

Device: Infraclavicular pocket cardiac microcurrent treatment

Coronary Sinus placement

Experimental group

Description:

A coronary sinus electrode will be placed instead of a patch

Treatment:

Device: Coronary Sinus cardiac microcurrent treatment