Bradycardia, Chronotropic Incompetence
Conditions
Keywords
Bradycardia, pacemaker
Brief summary
This study will collect data on features for future pacemakers via an external non-implantable system.
Detailed description
COGNATE is an acute, confirmatory prospective, multi-center study designed to gather data on Brady and CRT-P indicated patients, with no restrictions on the type/brand of leads. This study will enroll up to 80 patients in up to 12 centers. Total duration of the study is expected to be 9 months.
Interventions
None listed
Sponsors
University of Pittsburgh
Boston Scientific Corporation
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled to receive either Pacemaker (dual chamber) or CRT-P devices based on physician discretion * Patients who are willing and capable of participating in all testing associated with this Clinical Investigation * Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
* Patient enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study * Patients with a prosthetic mechanical tricuspid heart valve * Women who are pregnant
Countries
United States
Outcome results
None listed