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CompletedNCT01030705COGNATEUpdated Sep 29, 2011

Common Sensing and Right Ventricular Automatic Capture (COGNATE)

An observational study in Bradycardia and Chronotropic Incompetence, sponsored by Boston Scientific Corporation. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-29.

Sponsored by Boston Scientific Corporation · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Bradycardia
  • Chronotropic Incompetence

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Keywords

  • Bradycardia
  • pacemaker
03

In context

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's planned enrollment of 80 is below the median of 257 across 129 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic patients

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

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
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Study design

Time perspective
Retrospective
Enrollment
80 participants (estimated)
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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01030705
Lead sponsor
Boston Scientific Corporation
Collaborators
University of Pittsburgh
Responsible party
Sponsor
First posted
Dec 11, 2009
Start date
Nov 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Sep 29, 2011

Study contacts

Samir Saba, MD
principal investigator · Health Care Conusltant

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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