Evaluation of a New Cardiac Pacemaker

Nanostim, Inc.8 sites in 3 countries36 target enrollmentDecember 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block
Sponsor: Nanostim, Inc.
Enrollment: 36
Locations: 8
Primary Endpoint: Complication rate, where a complication is defined as a serious adverse device effect (SADE)
Last Updated: 12 years ago

An evaluation of a safety and performance of a new cardiac pacemaker

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

August 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.