Dual Site Left Ventricular (LV) Pacing

Congestive Heart Failure Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944125
• Other study ID #: L-08-166
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: February 4, 2014
• Start date: June 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. Slows the rate patients experience certain heart failure symptoms

4. Reduces uncoordinated heart contractions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• LV Dysfunction

Intervention

Device:
• Dual Site LV Pacing vs. BiV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.

Locations

Country	Name	City	State
United States	Aurora Cardiovascular Services	Lake Geneva	Wisconsin
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Aurora Health Care	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to three months as compared to the difference from three to six months within a patient.		6 months	No