Physiological Response to Exercise: Sensor Evaluation at Specified Exertions (PRE-SENSE)
This study has been completed.
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01229137
First received: October 25, 2010
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
Assessment of sensor parameter in patients with heart failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: SRD-1 conversion |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Physiological Response to Exercise: Sensor Evaluation at Specified Exertions |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
| Enrollment: | 71 |
| Study Start Date: | June 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Right Ventricular Cohort
Right Ventricle wtih SRD-1 conversion
|
Device: SRD-1 conversion |
|
Left Ventricular Cohort
Left Ventricle with SRD-1 conversion
|
Device: SRD-1 conversion |
|
Right Atrium Cohart
Right atrium cohort with SRD-1 conversion
|
Device: SRD-1 conversion |
Detailed Description:
Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.
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
Heart failure patients with an implanted CRT-D
Criteria
Inclusion Criteria:
- COGNIS CRT-D model N119 or N120, functional bipolar leads: RA, RV, and LV lead all implanted for a minimum of 30 days
- Prescribed to optimal pharmacologic therapy for heart failure for at least 30 days prior to enrollment
- Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
- Documented HF decompensation, as defined by a hospitalization or greater than a doubling of baseline diuretic dose due to worsening HF, within the last 3 months
- Patients who are pacemaker dependent
- Creatinine ≥ 2.5 mg/dL test within the last 3 months
- Requires assistance walking, for example a cane or walker
- Have an atrial tachyarrhythmia that is permanent or persistent
- Have moderate to severe chronic pulmonary disease as defined by FEV1 < 55% predicted
- Documented life expectancy of less than 6 months
- Patients at an unreasonable risk of not being able to reach the investigational center in case of an emergency, per physician discretion
- Enrolled in any concurrent study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229137
Locations
| United States, Arkansas | |
| Cardiovascular Associates of Northeast Arkansas | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Regional Cardiology Consultants | |
| Sacremento, California, United States, 95819 | |
| United States, Connecticut | |
| Danbury Hospital | |
| Danbury, Connecticut, United States, 06810 | |
| United States, Florida | |
| Heart and Vascular Institute of Florida | |
| Clearwater, Florida, United States, 33756 | |
| United States, Iowa | |
| Genesis Medical Center | |
| Davenport, Iowa, United States, 52803 | |
| United States, Massachusetts | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| St. John's Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| United States, Minnesota | |
| United Heart and Vascular Clinic | |
| St. Paul, Minnesota, United States, 55102 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Ohio | |
| Cardiovascular Research Institure, LLC | |
| Canton, Ohio, United States, 44708 | |
| United States, Texas | |
| Texas Cardiac Arrhythmia Research | |
| Austin, Texas, United States, 78705 | |
| Tyler Cardiovascular Associates | |
| Tyler, Texas, United States, 75701 | |
| United States, Utah | |
| Thomas Bunch | |
| Murray, Utah, United States, 84157 | |
| United States, Virginia | |
| University of Virginia Medical Center | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | Alan Bank, M.D. | United Heart and Vascular Center |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01229137 History of Changes |
| Other Study ID Numbers: | PRE-SENSE, G100110 |
| Study First Received: | October 25, 2010 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013