Evaluation of a New Cardiac Pacemaker

Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01700244
• Other study ID #: LCP004
• Status: Active, not recruiting
• Phase: N/A
• First received: October 2, 2012
• Last updated: June 25, 2013
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: June 2013
• Source: Nanostim, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: SUKL - State Institute for Drug ControlGermany: BfArM - Federal Institute for Drugs and Medical DevicesNetherlands: METC - Medical Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block
• Bradycardia
• Normal Sinus Rhythm With 2 or 3° AV or BBB Block
• Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings

Intervention

Device:
• Pacemaker implant

Locations

Country	Name	City	State
Czech Republic	IKEM	Prague 4
Czech Republic	Na Homolce Hospital	Prague 5	Prague
Germany	Kerckhoff Clinic	Bad Nauheim
Germany	University Hospital Leipzig	Leipzig
Germany	Heart Hospital Munich	Munich
Netherlands	Academic Medical Center	Amsterdam
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Nanostim, Inc.

Countries where clinical trial is conducted

Czech Republic,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate, where a complication is defined as a serious adverse device effect (SADE)		90 days	Yes