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

This study has been completed.

Sponsor:

Collaborator:

University of Pittsburgh

Information provided by (Responsible Party):

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT01030705

First received: December 9, 2009

Last updated: September 28, 2011

Last verified: September 2011

History of Changes

Purpose

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

Condition
Bradycardia Chronotropic Incompetence


Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Common Sensing and Right Ventricular Automatic Capture

Further study details as provided by Boston Scientific Corporation:


Estimated Enrollment:	80
Study Start Date:	November 2009
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic patients

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030705

Locations


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

Sponsors and Collaborators

Boston Scientific Corporation

University of Pittsburgh

Investigators


Principal Investigator:	Samir Saba, MD	Health Care Conusltant

More Information


Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01030705 History of Changes
Other Study ID Numbers:	COGNATE
Study First Received:	December 9, 2009
Last Updated:	September 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:


Bradycardia pacemaker

Additional relevant MeSH terms:


Bradycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016

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