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.

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

Study Overview

• Status: Terminated
• Conditions: Congestive Heart Failure; LV Dysfunction
• Intervention / Treatment: Device: Dual Site LV Pacing; Device: BiV Pacing

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Lake Geneva, Wisconsin, United States, 53147
      • Aurora Cardiovascular Services
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Cardiovascular Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dual Site LV Pacing; Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.	Device: Dual Site LV Pacing; Dual 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 vs. BiV Pacing for a total of six months which includes two three crossover periods.
Active Comparator: BiV Pacing; Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.	Device: Dual Site LV Pacing; Dual 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 vs. BiV Pacing for a total of six months which includes two three crossover periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imran Niazi
• Collaborators: Medtronic
• Investigators: Principal Investigator: Imran K Niazi, MD, Aurora Health Care

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 17, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): March 21, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: L-08-166