Common Sensing and Right Ventricular Automatic Capture (COGNATE)

Bradycardia Clinical Trial

— COGNATE  

Official title:

Common Sensing and Right Ventricular Automatic Capture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030705
• Other study ID #: COGNATE
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: September 28, 2011
• Start date: November 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2011
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bradycardia
• Chronotropic Incompetence

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	University of Pittsburgh

Country where clinical trial is conducted

United States,