Heart FailurePhase 4NCT00187200
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
A Phase 4 study testing Simultaneous VV Pacing and Sequential VV Pacing in people with Heart Failure, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate. 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?
- Simultaneous VV Pacing and Sequential VV Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient has a standard indication for a CRT-D.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
- Patients requiring a CRT-D replacement must comply with BOTH of the following:
- > 1 HF related hospitalization
- No class improvement or worsening in NYHA scale
Who cannot join
- Patient's life expectancy is less than 12 months.
- Patient has had cardiac surgery within 6 months of enrollment.
- Patient has an epicardial ventricular lead system.
- Patient is less than 18 years old.
- Patient is pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular (VV) Timing in Heart Failure Patients
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.
For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
Read more
- < 10% improvement in 6-minute hall walk, and
- no class improvement or worsening in New York Heart Association (NYHA) scale.
For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- > 1 heart failure (HF) related hospitalization, and
- no class improvement or worsening in NYHA scale.
Read the detailed description
Study Methods
- This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
- Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing is eligible for enrollment.
- At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
- Patients are followed for a period of 6 months post randomization:
- Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)
- Screening/Randomization Visit (3 months post enrollment)
- Follow-up Visit (6 months post randomization)
- Total # of centers - 80 centers
- Sample size - 800 patients screened for CRT non-responders
- Conditions
- Heart Failure
- Being tested
- Simultaneous VV Pacing, Sequential VV Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous VV PacingDevice
Right ventricular and left ventricular pacing delivered simultaneously.
Sequential VV PacingDevice
Right ventricular and left ventricular pacing delivered sequentially.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous VV Pacing | Active comparator | Programmed to simultaneous biventricular pacing Receives: Device: Simultaneous VV Pacing |
| Sequential VV Pacing | Active comparator | Programmed to sequential biventricular pacing Receives: Device: Sequential VV Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT Responder Rate
Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.
Measured: 6 months
Secondary outcomes (3)
NYHA Class Progression
New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.
Measured: 6 months
6 Minute Hall Walk Distance Test (6-MHWD)
Patients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.
Measured: 6 months
Left Ventricular Ejection Fraction (LVEF)
Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).
Measured: Randomization and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul Weiss, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187200
- Sponsor's protocol ID
- CRD299
- Status last verified
- Feb 2019
- First submitted
- 10 Sep 2005
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular (VV) Timing in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00187200
- Acronym / sponsor ID
- CRD299
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 25 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.
For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- < 10% improvement in 6-minute hall walk, and
- no class improvement or worsening in New York Heart Association (NYHA) scale.
For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- > 1 heart failure (HF) related hospitalization, and
- no class improvement or worsening in NYHA scale.
Detailed description
Study Methods
- This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
- Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing is eligible for enrollment.
- At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
- Patients are followed for a period of 6 months post randomization:
- Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)
- Screening/Randomization Visit (3 months post enrollment)
- Follow-up Visit (6 months post randomization)
- Total # of centers - 80 centers
- Sample size - 800 patients screened for CRT non-responders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous VV Pacing | Active comparator | Device: Simultaneous VV PacingProgrammed to simultaneous biventricular pacing |
| Sequential VV Pacing | Active comparator | Device: Sequential VV PacingProgrammed to sequential biventricular pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has a standard indication for a CRT-D.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
- Patients requiring a CRT-D replacement must comply with BOTH of the following:
Key exclusion criteria (5 listed)
- Patient's life expectancy is less than 12 months.
- Patient has had cardiac surgery within 6 months of enrollment.
- Patient has an epicardial ventricular lead system.
- Patient is less than 18 years old.
- Patient is pregnant.
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 |
|---|---|---|
| Simultaneous VV PacingRight ventricular and left ventricular pacing delivered simultaneously. | Device | Simultaneous VV Pacing |
| Sequential VV PacingRight ventricular and left ventricular pacing delivered sequentially. | Device | Sequential VV Pacing |
Primary outcome
CRT Responder Rate
Time frame: 6 months
Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.
3 secondary outcomes
NYHA Class Progression
Time frame: 6 months
6 Minute Hall Walk Distance Test (6-MHWD)
Time frame: 6 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: Randomization and 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raul Weiss, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simultaneous VV Pacing and Sequential VV Pacing in people with Heart Failure, run by Abbott Medical Devices at 1 site 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 7 inclusion and 5 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CRT Responder Rate (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 5 Feb 2019.