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Completed

NCT Number: NCT01030705

Common Sensing and Right Ventricular Automatic Capture (COGNATE)

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

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Chronotropic Incompetence Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Luke's Hospital, Cedar Rapids, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Common Sensing and Right Ventricular Automatic Capture

Acronym: COGNATE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2009
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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