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Evaluation of a New Cardiac Pacemaker

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pacemaker implant
Sponsored by
Nanostim, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Na Homolce Hospital
  • IKEM
  • Kerckhoff Clinic
  • University Hospital Leipzig
  • Heart Hospital Munich
  • Academic Medical Center
  • St. Antonius Hospital
  • UMC Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pacemaker

Arm Description

Outcomes

Primary Outcome Measures

Complication rate, where a complication is defined as a serious adverse device effect (SADE)

Secondary Outcome Measures

Full Information

First Posted
October 2, 2012
Last Updated
June 25, 2013
Sponsor
Nanostim, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01700244
Brief Title
Evaluation of a New Cardiac Pacemaker
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanostim, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pacemaker
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Pacemaker implant
Primary Outcome Measure Information:
Title
Complication rate, where a complication is defined as a serious adverse device effect (SADE)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Sperzel, MD
Organizational Affiliation
Kerckhoff Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Na Homolce Hospital
City
Prague 5
State/Province
Prague
ZIP/Postal Code
15000
Country
Czech Republic
Facility Name
IKEM
City
Prague 4
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Kerckhoff Clinic
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
University Hospital Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Heart Hospital Munich
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3430
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27932427
Citation
Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.
Results Reference
derived
PubMed Identifier
25881930
Citation
Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.
Results Reference
derived
PubMed Identifier
24664277
Citation
Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.
Results Reference
derived

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Evaluation of a New Cardiac Pacemaker

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