Overview

This trial is active, not recruiting.

Conditions 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
Treatment pacemaker implant
Sponsor Nanostim, Inc.
Start date December 2012
End date July 2013
Trial size 36 participants
Trial identifier NCT01700244, LCP004

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pacemaker implant

Primary Outcomes

Measure
Complication rate, where a complication is defined as a serious adverse device effect (SADE)
time frame: 90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Principal investigator Johannes Sperzel, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Nanostim, Inc..