Common Sensing and Right Ventricular Automatic Capture (COGNATE)
This study has been completed.
Sponsor:
Boston Scientific Corporation
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
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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) |
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 |
| 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
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
No publications provided
| 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 |
ClinicalTrials.gov processed this record on March 02, 2015