Phase
Condition
Arrhythmia
Low Blood Pressure (Hypotension)
Dysrhythmia
Treatment
Solia CSP S lead
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is a candidate for implantation of a BIOTRONIK pacemaker system, perstandard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
Patient has an implant planned to utilize left bundle branch area (LBBA) pacingwithin 30 days of consent
Patient is able to understand the nature of the study and provide written informedconsent
Patient is available for follow-up visits on a regular basis for the expectedduration of follow-up
Patient accepts Home Monitoring® concept
Patient age is greater than or equal to 18 years at time of consent
Exclusion
Exclusion Criteria:
Patient meets a standard contraindication for pacemaker system implant
Patient is currently implanted with a pacemaker or ICD device
Patient has had a previous unsuccessful attempt to place a lead in the LBBA
Patient has planned cardiac surgical procedures or interventional measures within 3months after implant
Patient is expected to receive a heart transplant within 12 months
Patient life expectancy less than 12 months
Patient has the presence of another life-threatening, underlying illness separatefrom their cardiac disorder
Patient reports pregnancy at the time of enrollment
Patient is enrolled in any other investigational cardiac clinical study during thecourse of the study
Study Design
Connect with a study center
Banner - University Medical Center Phoenix
Phoenix, Arizona 85006
United StatesActive - Recruiting
Cardiology Associates Medical Group
Ventura, California 93003
United StatesActive - Recruiting
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Cardiology Associates Research, LLC
Tupelo, Mississippi 38801
United StatesActive - Recruiting
NYU Heart Rhythm Center
New York, New York 10016
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10021
United StatesActive - Recruiting
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania 19301
United StatesActive - Recruiting
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania 18711
United StatesActive - Recruiting
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