Heart FailurePRE-SENSENCT01229137
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
An observational study of Heart Failure, run by Boston Scientific Corporation at 14 sites in United States.
Trial summary
Assessment of sensor parameter in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SRD-1 conversion
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2011to Aug 2012
- 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: Heart failure patients with an implanted CRT-D
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Cardiovascular Research Institure, LLC
Canton, Ohio, 44708
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Heart and Vascular Institute of Florida
Clearwater, Florida, 33756
Danbury Hospital
Danbury, Connecticut, 06810
Genesis Medical Center
Davenport, Iowa, 52803
St. John's Hospital and Medical Center
Detroit, Michigan, 48236
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiovascular Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401
Thomas Bunch
Murray, Utah, 84157
Regional Cardiology Consultants
Sacremento, California, 95819
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
Tyler Cardiovascular Associates
Tyler, Texas, 75701
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Assessment of sensor parameter in patients with heart failure.
Read the detailed description
Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- SRD-1 conversion
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRD-1 conversionDevice
| Study group | Role | What they receive |
|---|---|---|
| Right Ventricular Cohort | Right Ventricle wtih SRD-1 conversion Receives: Device: SRD-1 conversion | |
| Left Ventricular Cohort | Left Ventricle with SRD-1 conversion Receives: Device: SRD-1 conversion | |
| Right Atrium Cohart | Right atrium cohort with SRD-1 conversion Receives: Device: SRD-1 conversion |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Bank, M.D., Principal investigator, United Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229137
- Sponsor's protocol ID
- PRE-SENSE
- Other IDs
- G100110
- Acronym
- PRE-SENSE
- Status last verified
- Sep 2012
- First submitted
- 25 Oct 2010
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
- ClinicalTrials.gov ID
- NCT01229137
- Acronym / sponsor ID
- PRE-SENSE / PRE-SENSE
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Oct 2010 (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.
Assessment of sensor parameter in patients with heart failure.
Detailed description
Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right Ventricular Cohort | – | Device: SRD-1 conversionRight Ventricle wtih SRD-1 conversion |
| Left Ventricular Cohort | – | Device: SRD-1 conversionLeft Ventricle with SRD-1 conversion |
| Right Atrium Cohart | – | Device: SRD-1 conversionRight atrium cohort with SRD-1 conversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with an implanted CRT-D
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRD-1 conversion | Device | Left Ventricular Cohort, Right Atrium Cohart, Right Ventricular Cohort |
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 12 Sep 2012.
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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.
Alan Bank, M.D. principal investigator
United Heart and Vascular Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boston Scientific Corporation at 14 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 9 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 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 12 Sep 2012.