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Dual Site Left Ventricular (LV) Pacing (DIVA)

Primary Purpose

Congestive Heart Failure, LV Dysfunction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual Site LV Pacing
BiV Pacing
Sponsored by
Imran Niazi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aurora Cardiovascular Services
  • Aurora Cardiovascular Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dual Site LV Pacing

BiV Pacing

Arm Description

Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.

Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2009
Last Updated
March 2, 2016
Sponsor
Imran Niazi
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00944125
Brief Title
Dual Site Left Ventricular (LV) Pacing
Acronym
DIVA
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
for administrative reasons (no safety concerns), no analysis completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Imran Niazi
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, LV Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Site LV Pacing
Arm Type
Active Comparator
Arm Description
Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Arm Title
BiV Pacing
Arm Type
Active Comparator
Arm Description
Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Intervention Type
Device
Intervention Name(s)
Dual Site LV Pacing
Intervention Description
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Intervention Type
Device
Intervention Name(s)
BiV Pacing
Intervention Description
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Systolic Volume (LVESV)
Description
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.
Time Frame
At 6 months to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran K Niazi, MD
Organizational Affiliation
Aurora Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Cardiovascular Services
City
Lake Geneva
State/Province
Wisconsin
ZIP/Postal Code
53147
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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Dual Site Left Ventricular (LV) Pacing

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