Evaluation of a New Cardiac Pacemaker

Not Applicable

• 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
• Interventions: Device: Pacemaker implant

• Registration Number: NCT01700244
• Lead Sponsor: Nanostim, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Study Start: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26
• Primary Completion: 2013-07
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pacemaker	Pacemaker implant	-

Primary Outcome Measures

Name	Time	Method
Complication rate, where a complication is defined as a serious adverse device effect (SADE)	90 days

Trial Locations

Locations (8)

University Hospital Leipzig; 🇩🇪 Leipzig, Germany

Na Homolce Hospital; 🇨🇿 Prague 5, Prague, Czech Republic

IKEM; 🇨🇿 Prague 4, Czech Republic

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Heart Hospital Munich; 🇩🇪 Munich, Germany

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Kerckhoff Clinic; 🇩🇪 Bad Nauheim, Germany