Congestive Heart FailureDIVANCT00944125
Dual Site Left Ventricular (LV) Pacing
A study testing Dual Site LV Pacing and BiV Pacing in people with Congestive Heart Failure and LV Dysfunction, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing: 1. Improves the way the heart's left ventricle functions 2. Decreases the number of hospital and clinic visits for heart failure related symptoms 3. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Congestive Heart Failure, LV Dysfunction
- What is being tested?
- Dual Site LV Pacing and BiV Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Jul 2013
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
- On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
- A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration > 120 ms
- Left ventricular ejection fraction (LVEF) < 35% or equal
- Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
- Have a life expectancy of more than 180 days, per physician discretion
- Age 40 or above, ensuring of legal age to give informed consent specific to state and national law
Who cannot join
- Have had previous cardiac resynchronization therapy or a previous coronary venous lead
- Unable to perform a Six-Minute Hall Walk (6MHW) Test
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
- Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
- Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- Have a mechanical tricuspid prosthesis
Show all 9Show fewer
- Has severe aortic or mitral stenosis
- Enrolled in any concurrent study that may confound the results of this study
- Patients who are or suspect they may be pregnant or plan to become pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aurora Cardiovascular Services
Lake Geneva, Wisconsin, 53147
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
About this study
Official title: Dual Site LV Pacing Study: Prospective Randomized Blinded Crossover Study of Patients Meeting Current CRT-D Indication to be Implanted With Dual LV Pacing Leads and Paced Chronically for at Least 6 Months Post-implant.
The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:
- Improves the way the heart's left ventricle functions
- Decreases the number of hospital and clinic visits for heart failure related symptoms
- Slows the rate patients experience certain heart failure symptoms
- Reduces uncoordinated heart contractions
- Conditions
- Congestive Heart Failure, LV Dysfunction
- Being tested
- Dual Site LV Pacing, BiV Pacing
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Site LV PacingDevice
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
BiV PacingDevice
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
| Study group | Role | What they receive |
|---|---|---|
| Dual Site LV Pacing | Active comparator | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Receives: Device: Dual Site LV Pacing; Device: BiV Pacing |
| BiV Pacing | Active comparator | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Receives: Device: Dual Site LV Pacing; Device: BiV Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular End Systolic Volume (LVESV)
The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.
Measured: At 6 months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: for administrative reasons (no safety concerns), no analysis completed
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 Congestive Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Imran K Niazi, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944125
- Sponsor's protocol ID
- L-08-166
- Acronym
- DIVA
- Status last verified
- Mar 2016
- First submitted
- 17 Jul 2009
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Site LV Pacing Study: Prospective Randomized Blinded Crossover Study of Patients Meeting Current CRT-D Indication to be Implanted With Dual LV Pacing Leads and Paced Chronically for at Least 6 Months Post-implant.
- ClinicalTrials.gov ID
- NCT00944125
- Acronym / sponsor ID
- DIVA / L-08-166
- Conditions
- Congestive Heart Failure, LV Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for administrative reasons (no safety concerns), no analysis completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Posted 21 Mar 2016
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 this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:
- Improves the way the heart's left ventricle functions
- Decreases the number of hospital and clinic visits for heart failure related symptoms
- Slows the rate patients experience certain heart failure symptoms
- Reduces uncoordinated heart contractions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Site LV Pacing | Active comparator | Device: Dual Site LV Pacing, Device: BiV PacingProspective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. |
| BiV Pacing | Active comparator | Device: Dual Site LV Pacing, Device: BiV PacingProspective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
- On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
- A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration > 120 ms
- Left ventricular ejection fraction (LVEF) < 35% or equal
- Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
Key exclusion criteria (9 listed)
- Have had previous cardiac resynchronization therapy or a previous coronary venous lead
- Unable to perform a Six-Minute Hall Walk (6MHW) Test
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
- Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
- Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
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 |
|---|---|---|
| Dual Site LV PacingDual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods. | Device | BiV Pacing, Dual Site LV Pacing |
| BiV PacingDual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods. | Device | BiV Pacing, Dual Site LV Pacing |
Primary outcome
Change in Left Ventricular End Systolic Volume (LVESV)
Time frame: At 6 months to one year
The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
Imran K Niazi, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Site LV Pacing and BiV Pacing in people with Congestive Heart Failure and LV Dysfunction, run by Wake Forest University Health Sciences at 2 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 7 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: stopped early, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 21 Mar 2016). 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?
Change in Left Ventricular End Systolic Volume (LVESV) (time frame: At 6 months to one year). 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 21 Oct 2024.