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
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nanostim, Inc.:

Primary Outcome Measures:
  • Complication rate, where a complication is defined as a serious adverse device effect (SADE) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: December 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pacemaker Device: Pacemaker implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700244

Locations
Czech Republic
Na Homolce Hospital
Prague 5, Prague, Czech Republic, 15000
IKEM
Prague 4, Czech Republic, 140 21
Germany
Kerckhoff Clinic
Bad Nauheim, Germany, 61231
University Hospital Leipzig
Leipzig, Germany, 04103
Heart Hospital Munich
Munich, Germany, 80636
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105
St. Antonius Hospital
Nieuwegein, Netherlands, 3430
UMC Utrecht
Utrecht, Netherlands, 3584
Sponsors and Collaborators
Nanostim, Inc.
Investigators
Principal Investigator: Johannes Sperzel, MD Kerckhoff Clinic
  More Information

No publications provided

Responsible Party: Nanostim, Inc.
ClinicalTrials.gov Identifier: NCT01700244     History of Changes
Other Study ID Numbers: LCP004
Study First Received: October 2, 2012
Last Updated: June 25, 2013
Health Authority: Czech Republic: SUKL - State Institute for Drug Control
Germany: BfArM - Federal Institute for Drugs and Medical Devices
Netherlands: METC - Medical Ethics Review Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Syncope
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014