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Common Sensing and Right Ventricular Automatic Capture (COGNATE)

NCT ID: NCT01030705

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Bradycardia Chronotropic Incompetence

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samir Saba, MD

Role: PRINCIPAL_INVESTIGATOR

Health Care Conusltant

Locations

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St. Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Nebraska Heart Institute

Lincoln, Nebraska, United States

Site Status

University of Pittsburgh Medical Center, Cardiac Electrophysiology

Pittsburgh, Pennsylvania, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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COGNATE

Identifier Type: -

Identifier Source: org_study_id