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Dual Site Left Ventricular (LV) Pacing (DIVA)

This study has been terminated.
(for administrative reasons (no safety concerns), no analysis completed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944125
First Posted: July 23, 2009
Last Update Posted: March 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Imran Niazi, Aurora Health Care
  Purpose

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

Condition Intervention
Congestive Heart Failure LV Dysfunction Device: Dual Site LV Pacing Device: BiV Pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.

Further study details as provided by Imran Niazi, Aurora Health Care:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: June 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944125


Locations
United States, Wisconsin
Aurora Cardiovascular Services
Lake Geneva, Wisconsin, United States, 53147
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Imran Niazi
Medtronic
Investigators
Principal Investigator: Imran K Niazi, MD Aurora Health Care
  More Information

Responsible Party: Imran Niazi, Physician of Aurora Health Care, Aurora Health Care
ClinicalTrials.gov Identifier: NCT00944125     History of Changes
Other Study ID Numbers: L-08-166
First Submitted: July 17, 2009
First Posted: July 23, 2009
Results First Submitted: February 25, 2015
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases