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ClinicalTrials.gov Identifier: NCT01700244
Recruitment Status : Unknown
Verified June 2013 by Nanostim, Inc.. Recruitment status was: Active, not recruiting
An evaluation of a safety and performance of a new cardiac pacemaker
Condition or disease
Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) BlockNormal Sinus Rhythm With 2 or 3° AV or BBB BlockSinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject must have one of the following clinical indications:
Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or
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
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.
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);