Heart FailureNCT00146874
CRT RENEWAL Registry
An observational study of Heart Failure, run by Boston Scientific Corporation.
Trial summary
This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life. 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?
- cardiac resynchronization therapy
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Mar 2007
- 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: Standard CRT population
Who may be able to join
- Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
- Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
- Patients who have had an ejection fraction measured within six months of enrollment
- Patients who sign and date a Patient Informed Consent form at the enrollment visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
Who cannot join
- Patients who are expected to receive a heart transplant during the duration of the registry
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
- Patients who are younger than 18 years of age
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
- Patients who are pregnant
About this study
Official title: Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices
This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.
Read the detailed description
The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. The registry will also assess clinical outcomes including quality of life (QOL), physical activity habits, and events rates, along with device diagnostics such as Activity Log Index and heart rate
- Conditions
- Heart Failure
- Being tested
- cardiac resynchronization therapy
- Medical subject headings
- Heart Failure
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 posted7 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2007
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Kaplan, MD, Principal investigator, Tri-City Cardiology Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146874
- Sponsor's protocol ID
- CR-CA-042704-H
- Status last verified
- Nov 2006
- First submitted
- 2 Sep 2005
- Last updated
- 18 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices
- ClinicalTrials.gov ID
- NCT00146874
- Acronym / sponsor ID
- CR-CA-042704-H
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Mar 2007 (actual)
- First posted
- 7 Sep 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.
This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.
Detailed description
The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. The registry will also assess clinical outcomes including quality of life (QOL), physical activity habits, and events rates, along with device diagnostics such as Activity Log Index and heart rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Standard CRT population
Key inclusion criteria (5 listed)
- Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
- Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
- Patients who have had an ejection fraction measured within six months of enrollment
- Patients who sign and date a Patient Informed Consent form at the enrollment visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
Key exclusion criteria (6 listed)
- Patients who are expected to receive a heart transplant during the duration of the registry
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
- Patients who are younger than 18 years of age
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
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 18 Aug 2010.
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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.
Andrew Kaplan, MD principal investigator
Tri-City Cardiology Consultants
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, 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 5 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 18 Aug 2010. 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 18 Aug 2010.