Common Sensing and Right Ventricular Automatic Capture (COGNATE)
- Conditions
- BradycardiaChronotropic Incompetence
- Registration Number
- NCT01030705
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This study will collect data on features for future pacemakers via an external non-implantable system.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
University of Pittsburgh Medical Center, Cardiac Electrophysiology
🇺🇸Pittsburgh, Pennsylvania, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals
🇺🇸Richmond, Virginia, United States
St. Luke's Hospital🇺🇸Cedar Rapids, Iowa, United States