Phase
Condition
Cardiac Disease
Arrhythmia
Low Blood Pressure (Hypotension)
Treatment
Reconditioned Pacemaker
New Pacemaker
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Life expectancy ≥ 2 years.
Indications for device implantation must be fulfilled per standard of care.Consistent with 2008 American College of Cardiology / American Heart Associationguidelines for device therapy, one of the following class I indications must be met.
Sinus Node Dysfunction
Acquired Atrioventricular (AV) Block
Chronic Bifascicular Block
Hypersensitive Carotid Syndrome
Lack of financial ability to pay for a new device must be assessed and documented.
All other methods of new device acquisition must be exhausted.
Patient must be agreeable and able to follow-up with the implanting center within 2weeks for wound check, at 2 months, 6 months, and every 6 months thereafter forroutine pacemaker checks.
Exclusion
Exclusion Criteria:
Severe valvular disease
Severe pulmonary disease
End-stage renal disease (creatinine clearance < 30 mL/min) whether or not ondialysis
Evidence of ongoing systemic infection
Prior pacemaker or implantable cardioverter-defibrillator implantation
Significant contraindication to pacemaker implantation per evaluation of theimplanting physician (very high risk of complications).
Presence of any other condition that the local investigator feels would beproblematic or would restrict or limit the participation of the patient for theentire study period
Pregnant women
Study Design
Connect with a study center
The Moi Teaching and Referral Hospital
Eldoret,
KenyaSite Not Available
Universidad Autonoma de Nuevo Leon
Monterrey,
MexicoSite Not Available
Hospital Central de Maputo
Maputo,
MozambiqueSite Not Available
LASUTH
Ikeja, Lagos 101233
NigeriaSite Not Available
Port Harcourt Teaching Hospital
Port Harcourt, Rivers
NigeriaSite Not Available
FUNDACOR
Asunción,
ParaguaySite Not Available
Choithram Memorial Hospital
Freetown,
Sierra LeoneSite Not Available
ASCARDIO
Barquisimeto, Lara 3001
VenezuelaSite Not Available

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