Adults patients that have indication for first implantation of a cardiac implatable medical device (cardiac pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device).
Conditions
Interventions
Group 1: Patients indicated for first implantation of a CIED (cardiac pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device).
Hylomate is folded around the CIED a
Sponsors
Hylomorph AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Able and willing to provide voluntary written Informed Consent as well as granted signature in the inform consent form to participate in the study prior to any study related procedure. 2 - Indication for first implantation of a CIED (cardiac pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device). 3 - Subject aged 18 years and over.
Exclusion criteria
Exclusion criteria: 1- Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, cf. § 20 Abs. 1 S. 4 No. 3 MPG or in a dependency relationship with sponsor, testing center or investigator. 2 - Any condition which could interfere with the subject’s ability to comply with the study. 3 - Ongoing participation in an interventional clinical study or during the preceding 30 days. 4 - Female subjects who are pregnant or lactating. 5- Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included. Note: A highly effective method of birth control and one which is acceptable for this study, is defined as one that can achieve a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. 6 - Active skin or deep infection at the implantation-site. 7 - History of chronic wounds or wound-healing disorders. 8- Subjects who underwent previous radiation near the location of the implant. 9 - Connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta). 10 - Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion). 11- Concomitant steroid therapy and/or other constant anti-inflammatory therapies. 12 -Subjects with end-stage chronic-renal disease / dialysis. 13 - Subjects with end-stage severe renal disease and either heart failure or low ejection fraction. 14- Subjects with consumptive / malignant primary disease and a life expectancy of less than 60 months/5 years. 15 -Any contra-indication for implantation of CIED or Hylomate. 16 - Patients with predisposition for the development of Twiddler’s syndrome (e.g. athletes following an intensive physical exercise routine). 17 - Subjects who have been diagnosed with an active SARS-CoV-2 infection or who are suspected to suffer from a COVID-19 disease are to be excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: Presence of Hylomate as a separation layer between CIED and surrounding tissues, as demonstrated non-invasively by external ultrasound at 12 months post-surgery. The definition of a successful measurement is a detectable separation layer, with no visible signs of rupture or tissue ingrowth across the CIED surface. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints (12 months) Effectiveness: Thickness of fibrotic capsule around the implant at the Hylomate/tissue interface as measured by ultrasound at 12 months post-surgery. Measurements at 1 and 6 months will provide supportive data. Evaluation of explant of the CIED if needed during the trial, i.e. time of explant surgery, surgery complications, ease of recoverability of leads. Rate of device pocket-related complication and surgical device pocket revision Usability: Ease of Hylomate handling and ability to position and fix the membrane as needed and as according to the Instructions For Use/ IFU (usability questionnaire); Evaluation of user learning curve | — |
Countries
Germany
Contacts
Public ContactSimone Bottan
Hylomorph AG
Outcome results
None listed