Common Sensing and Right Ventricular Automatic Capture (COGNATE)

Boston Scientific Corporation80 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bradycardia Chronotropic Incompetence

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

University of Pittsburgh Medical Center, Cardiac Electrophysiology

Pittsburgh, Pennsylvania, United States

Intermountain Medical Center

Murray, Utah, United States

Data from ClinicalTrials.gov

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