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Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy. (INCREMENTAL)

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ClinicalTrials.gov Identifier: NCT00399594
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : November 24, 2015
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Medtronic
Hoffmann-La Roche
Cambridge Heart Inc.
Information provided by (Responsible Party):
Dr. Derek Exner, University of Calgary

November 13, 2006
November 15, 2006
November 24, 2015
March 2011
April 2014   (Final data collection date for primary outcome measure)
Change in end systolic volume plus reduction in symptoms [ Time Frame: over 12 months ]
Response to cardiac resynchronization therapy (reduction in end systolic volume and reduction in symptoms).
Complete list of historical versions of study NCT00399594 on ClinicalTrials.gov Archive Site
  • Minnesota Living with Heart Failure score. [ Time Frame: Change over 12 months ]
  • Short form thirty six score. [ Time Frame: Change over 12 months ]
  • Specific Activity Scale score. [ Time Frame: Change over 12 months ]
  • New York Heart Association class. [ Time Frame: Change over 12 months ]
  • Six minute walk distance. [ Time Frame: Change over 12 months ]
  • LV volumes. [ Time Frame: Change over 12 months ]
  • N-terminal pro-B-type natriuretic peptide. [ Time Frame: Change over 12 months ]
  • Mortality [ Time Frame: Study duration ]
  • Hospitalization [ Time Frame: Study duration ]
  • Minnesota Living with Heart Failure score.
  • Short form thirty six score.
  • Specific Activity Scale score.
  • New York Heart Association class.
  • Six minute walk distance.
  • Augmentation in regional LV systolic function with dobutamine.
  • LV volumes.
  • N-terminal pro-B-type natriuretic peptide.
  • Microvolt alternans voltage.
Not Provided
Not Provided
 
Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).

Identifying & optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death & hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output & reduces HF symptoms. However, ~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.

This study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.

Background. Identifying & optimizing strategies to reduce the burden of heart failure (HF) is vital. Despite advances in pharmacotherapy, patients with HF are at high risk for death & hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular contraction that results in paradoxical septal motion, further impairing left ventricular (LV) function & HF progression. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output & reduces HF symptoms. However, ~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.

Screening. Mechanical synchrony is vitally important in optimizing CRT response. Patients will be pre-screened with echocardiograms (echo) & CRT provided to only those with dyssynchrony. The predicted rate of CRT response in patients pre-screened for dyssynchrony is estimated at 65%.

CRT response. The combined use of a valid & simple measure of functional capacity with a reproducible measure of LV volume is optimal in identifying CRT responders. These outcomes will be assessed using the Specific Activity Scale & radionuclide angiography (RNA), respectively.

Primary hypothesis. Targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement. CRT response will be defined as ≥ 10% relative reduction in LV end systolic volume & ≥ 1 Specific Activity Scale class improvement.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure, Congestive
  • Cardiac Pacing, Artificial
  • Defibrillators
  • Procedure: A
    LV lead placement in region of latest mechanical velocity (tissue doppler)
  • Procedure: B
    LV lead placement in standard (lateral / posterolateral) position.
  • Experimental: A
    Targeted LV lead placement
    Intervention: Procedure: A
  • Active Comparator: B
    Usual LV lead placement
    Intervention: Procedure: B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
300
November 2015
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • LV EF ≤ 0.40 measured within 3 months of enrollment,
  • SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.
  • Confirmed dyssynchrony on screening echo (1.1.9), &
  • On stable doses of ACE inhibitor or angiotensin II blocker & a beta-blocker for ≥ 2 months unless medically contra-indicated.
  • Controlled heart rate if in permanent AF (resting <70 & maximal <120).

Exclusion Criteria:

  • Unable or unwilling to provide informed consent,
  • Medical condition other than heart failure likely to cause death < 1 year,
  • Cardiac transplant planned within 6 months,
  • Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),
  • Clinically significant myocardial infarction within last 2 months, or
  • Coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00399594
CAH 70-3402
Yes
Not Provided
Not Provided
Dr. Derek Exner, University of Calgary
University of Calgary
  • Canadian Institutes of Health Research (CIHR)
  • Medtronic
  • Hoffmann-La Roche
  • Cambridge Heart Inc.
Principal Investigator: Derek V Exner, MD, MPH Libin Cardiovascular Institute of Alberta, University of Calgary
University of Calgary
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP