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Common Sensing and Right Ventricular Automatic Capture (COGNATE)

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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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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