Congestive Heart FailureVRRNCT00583921
Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF
An observational study of Congestive Heart Failure and Atrial Fibrillation, run by University of California, Davis.
Trial summary
Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure, Atrial Fibrillation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with a new Guidant ICD/ CRT-D: Indication for CRT-D and ICD with history of atrial fibrillation. Patients with new implants will not be enrolled until their three month follow up visit in the pacemaker clinic. Patients currenlty implanted with a Guidant ICD/ CRT-D: More than 20% atrial fibrillation burden as recorded by defibrillator follow up report or with history of atrial fibrillation.
Who may be able to join
- Be between 18-85 years old
- Be willing and able to give informed consent
- Patient currently has a CRT-D or ICD with > 20% atrial fibrillation burden as recorded by defibrillator follow up report or a history of atrial fibrillation prior to implant.
- Patient has the ability to complete a Six minute walk test with the only limiting factors to be fatigue or shortness of breath.
Who cannot join
- Expected mortality less than 6 months due to non-cardiac causes.
- Pregnant women.
- Creatinine greater than or equal to 2.5 mg/dl.
- Anemia (HCT less than 30)
- COPD causing significant dyspnea
- Orthopedic problems affecting 6 minute walk.
About this study
Official title: Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.
Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden.
- Conditions
- Congestive Heart Failure, Atrial Fibrillation
- Keywords
- Atrial Fibrillation, ICD, BiV ICD, CHF, Congestive Heart Failure, AF
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
Why it stopped: no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Guidant Corporation
- Responsible party
- Sponsor
- Investigators
- Uma Srivatsa, MD, Principal investigator, U C Davis Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583921
- Sponsor's protocol ID
- 200614770
- Acronym
- VRR
- Status last verified
- Jul 2017
- First submitted
- 26 Dec 2007
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT00583921
- Acronym / sponsor ID
- VRR / 200614770
- Conditions
- Congestive Heart Failure, Atrial Fibrillation
- Keywords
- Atrial Fibrillation, ICD, BiV ICD, CHF, Congestive Heart Failure, AF
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Guidant Corporation
- First posted
- 2 Jan 2008 (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.
Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a new Guidant ICD/ CRT-D: Indication for CRT-D and ICD with history of atrial fibrillation. Patients with new implants will not be enrolled until their three month follow up visit in the pacemaker clinic. Patients currenlty implanted with a Guidant ICD/ CRT-D: More than 20% atrial fibrillation burden as recorded by defibrillator follow up report or with history of atrial fibrillation.
Key inclusion criteria (4 listed)
- Be between 18-85 years old
- Be willing and able to give informed consent
- Patient currently has a CRT-D or ICD with > 20% atrial fibrillation burden as recorded by defibrillator follow up report or a history of atrial fibrillation prior to implant.
- Patient has the ability to complete a Six minute walk test with the only limiting factors to be fatigue or shortness of breath.
Key exclusion criteria (6 listed)
- Expected mortality less than 6 months due to non-cardiac causes.
- Pregnant women.
- Creatinine greater than or equal to 2.5 mg/dl.
- Anemia (HCT less than 30)
- COPD causing significant dyspnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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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.
Uma Srivatsa, MD principal investigator
U C Davis Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Atrial Fibrillation, run by University of California, Davis.
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 4 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: withdrawn, as of the sponsor's last update on 13 Jul 2017. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 13 Jul 2017.