Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block, Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings
Conditions
Brief summary
An evaluation of a safety and performance of a new cardiac pacemaker
Interventions
DEVICEPacemaker implant
Sponsors
Nanostim, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must have one of the following clinical indications: 1. Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or 2. Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or 3. Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and * Subject ≥18 years of age; * Subject has life expectancy of at least one year; * Subject is not enrolled in another clinical investigation; * Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; * Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; * If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
Exclusion criteria
* Pacemaker dependent; * Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; * Hypersensitivity to \< 1 mg of dexamethasone sodium phosphate; * Mechanical tricuspid valve prosthesis; * Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease; * Pre-existing pacing or defibrillation leads; * Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); * Presence of implanted vena cava filter; * Presence of implanted leadless cardiac pacemaker; * Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complication rate, where a complication is defined as a serious adverse device effect (SADE) | 90 days |
Countries
Czechia, Germany, Netherlands
Outcome results
None listed