Common Sensing and Right Ventricular Automatic Capture (COGNATE)

Boston Scientific

Status: Completed

Conditions: Bradycardia; Chronotropic Incompetence

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01030705

COGNATE

Details and patient eligibility

About

This study will collect data on features for future pacemakers via an external non-implantable system.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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