Common Sensing and Right Ventricular Automatic Capture (COGNATE) (COGNATE)

September 28, 2011 updated by: Boston Scientific Corporation

Common Sensing and Right Ventricular Automatic Capture

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Cedar Rapids, Iowa, United States, 52043
        • St. Luke's Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center, Cardiac Electrophysiology
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

University of Pittsburgh

Investigators

  • Principal Investigator: Samir Saba, MD, Health Care Conusltant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COGNATE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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