Evaluation of a New Cardiac Pacemaker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-08-31

Brief Summary

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

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pacemaker

Group Type EXPERIMENTAL

Pacemaker implant

Intervention Type DEVICE

Interventions

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Pacemaker implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No