Evaluation of a New Cardiac Pacemaker

June 25, 2013 updated by: Nanostim, Inc.
An evaluation of a safety and performance of a new cardiac pacemaker

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague 4, Czech Republic, 140 21
        • IKEM
    • Prague
      • Prague 5, Prague, Czech Republic, 15000
        • Na Homolce Hospital
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Clinic
      • Leipzig, Germany, 04103
        • University Hospital Leipzig
      • Munich, Germany, 80636
        • Heart Hospital Munich
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academic Medical Center
      • Nieuwegein, Netherlands, 3430
        • St. Antonius Hospital
      • Utrecht, Netherlands, 3584
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pacemaker
Device: Pacemaker implant

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanostim, Inc.

Investigators

  • Principal Investigator: Johannes Sperzel, MD, Kerckhoff Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2013

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCP004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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