Heart FailureNCT00236236
The HF-HRV Registry
An observational study of Heart Failure and Arrhythmia, run by Boston Scientific Corporation.
Trial summary
The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy 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, Arrhythmia
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to May 2005
- 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
Who may be able to join
- Patients receiving their first CRT-D
- Patients who sign and date a Patient Informed Consent prior to device implant
- Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled
Who cannot join
- Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
- Patients who are younger than 18 years of age
- Patients whose life expectancy is less than six-months due to other medical conditions
- Patients with or who are likely to receive a tricuspid or other valve prosthesis
- Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
- Women who are pregnant
About this study
Official title: CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry
The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.
- Conditions
- Heart Failure, Arrhythmia
- Being tested
- Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startFeb 2003
- Study completionMay 2005
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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kellie Chase, Study chair, Guidant Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236236
- Sponsor's protocol ID
- CR-CA-022103-H
- Status last verified
- Oct 2005
- First submitted
- 2 Sep 2005
- Last updated
- 14 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry
- ClinicalTrials.gov ID
- NCT00236236
- Acronym / sponsor ID
- CR-CA-022103-H
- Conditions
- Heart Failure, Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- May 2005
- First posted
- 12 Oct 2005 (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.
The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving their first CRT-D
- Patients who sign and date a Patient Informed Consent prior to device implant
- Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled
Key exclusion criteria (6 listed)
- Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
- Patients who are younger than 18 years of age
- Patients whose life expectancy is less than six-months due to other medical conditions
- Patients with or who are likely to receive a tricuspid or other valve prosthesis
- Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
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 |
|---|---|---|
| Cardiac Resynchronization Therapy | Device | – |
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 14 Nov 2006.
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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.
Kellie Chase study chair
Guidant Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Arrhythmia, run by Boston Scientific Corporation.
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 6 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 14 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
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 14 Nov 2006.