Clinical trial NCT01700244: Evaluation of a New Cardiac Pacemaker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Nanostim, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An evaluation of a safety and performance of a new cardiac pacemaker


Eligibility 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.

Primary outcomes:
measure: Complication rate, where a complication is defined as a serious adverse device effect (SADE)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Prague 5
country: Czech Republic
facility: Na Homolce Hospital
state: Prague
city: Prague 4
country: Czech Republic
facility: IKEM
city: Bad Nauheim
country: Germany
facility: Kerckhoff Clinic
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Munich
country: Germany
facility: Heart Hospital Munich
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Kerckhoff Clinic
name: Johannes Sperzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.