Study Stopped
for administrative reasons (no safety concerns), no analysis completed
Dual Site Left Ventricular (LV) Pacing
DIVA
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.
1 other identifier
interventional
50
1 country
2
Brief 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.Slows the rate patients experience certain heart failure symptoms
- 4.Reduces uncoordinated heart contractions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 17, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
March 21, 2016
CompletedOctober 21, 2024
March 1, 2016
4.1 years
July 17, 2009
February 25, 2015
October 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At 6 months to one year
Study Arms (2)
Dual Site LV Pacing
ACTIVE COMPARATORProspective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
BiV Pacing
ACTIVE COMPARATORProspective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Interventions
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- Medtroniccollaborator
Study Sites (2)
Aurora Cardiovascular Services
Lake Geneva, Wisconsin, 53147, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study terminated early form administrative reasons (no safety concerns), no analysis was completed.
Results Point of Contact
- Title
- Imran K. Niazi, MD
- Organization
- Aurora Health Care
Study Officials
- PRINCIPAL INVESTIGATOR
Imran K Niazi, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2009
First Posted
July 23, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 21, 2024
Results First Posted
March 21, 2016
Record last verified: 2016-03