Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00399594
First received: November 13, 2006
Last updated: November 20, 2015
Last verified: November 2015
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Cardiac Pacing, Artificial
Defibrillators
 Procedure: A
Procedure: B
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in end systolic volume plus reduction in symptoms [ Time Frame: over 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minnesota Living with Heart Failure score. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • Short form thirty six score. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • Specific Activity Scale score. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • New York Heart Association class. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • Six minute walk distance. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • LV volumes. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • N-terminal pro-B-type natriuretic peptide. [ Time Frame: Change over 12 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
  • Hospitalization [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Enrollment: 96
Study Start Date: March 2011
Study Completion Date: November 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Targeted LV lead placement
 Procedure: A
LV lead placement in region of latest mechanical velocity (tissue doppler)
Active Comparator: B
Usual LV lead placement
 Procedure: B
LV lead placement in standard (lateral / posterolateral) position.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399594

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N4N1
Canada, Ontario
London Health Sciences
London, Ontario, Canada
Canada, Quebec
Quebec Heart Institute
Ste-Foy, Quebec, Canada, G1V4G5
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Medtronic
Hoffmann-La Roche
Cambridge Heart Inc.
Investigators
Principal Investigator: Derek V Exner, MD, MPH Libin Cardiovascular Institute of Alberta, University of Calgary
  More Information

Responsible Party: Dr. Derek Exner, Professor and Canada Research Chair in Cardiovascular Clinical Trials, University of Calgary
ClinicalTrials.gov Identifier: NCT00399594     History of Changes
Other Study ID Numbers: CAH 70-3402 
Study First Received: November 13, 2006
Last Updated: November 20, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Mechanical dyssynchrony
Biventricular pacing
Cardiac resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016