Evaluation of a New Cardiac Pacemaker

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nanostim, Inc.
ClinicalTrials.gov Identifier:
NCT01700244
First received: October 2, 2012
Last updated: June 25, 2013
Last verified: June 2013

October 2, 2012
June 25, 2013
December 2012
July 2013   (final data collection date for primary outcome measure)
Complication rate, where a complication is defined as a serious adverse device effect (SADE) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01700244 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Evaluation of a New Cardiac Pacemaker
Not Provided

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Device: Pacemaker implant
Experimental: Pacemaker
Intervention: Device: Pacemaker implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
August 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Netherlands
 
NCT01700244
LCP004
Yes
Nanostim, Inc.
Nanostim, Inc.
Not Provided
Principal Investigator: Johannes Sperzel, MD Kerckhoff Clinic
Nanostim, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP