BradycardiaCOGNATENCT01030705
Common Sensing and Right Ventricular Automatic Capture (COGNATE)
An observational study of Bradycardia and Chronotropic Incompetence, run by Boston Scientific Corporation at 5 sites in United States.
Trial summary
This study will collect data on features for future pacemakers via an external non-implantable system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Chronotropic Incompetence
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Luke's Hospital
Cedar Rapids, Iowa, 52043
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Intermountain Medical Center
Murray, Utah, 84107
University of Pittsburgh Medical Center, Cardiac Electrophysiology
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University Health System, Medical College of Virginia, MCV Physicians and Hospitals
Richmond, Virginia, 23298
About this study
Official title: Common Sensing and Right Ventricular Automatic Capture
This study will collect data on features for future pacemakers via an external non-implantable system.
Read the 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.
- Conditions
- Bradycardia, Chronotropic Incompetence
- Keywords
- Bradycardia, pacemaker
- Medical subject headings
- Bradycardia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Samir Saba, MD, Principal investigator, Health Care Conusltant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030705
- Sponsor's protocol ID
- COGNATE
- Acronym
- COGNATE
- Status last verified
- Sep 2011
- First submitted
- 9 Dec 2009
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Sensing and Right Ventricular Automatic Capture
- ClinicalTrials.gov ID
- NCT01030705
- Acronym / sponsor ID
- COGNATE / COGNATE
- Conditions
- Bradycardia, Chronotropic Incompetence
- Keywords
- Bradycardia, pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Saba, MD principal investigator
Health Care Conusltant
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Chronotropic Incompetence, run by Boston Scientific Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2011.