Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy. (INCREMENTAL)
Primary Purpose
Heart Failure, Congestive, Cardiac Pacing, Artificial, Defibrillators
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
A
B
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Mechanical dyssynchrony, Biventricular pacing, Cardiac resynchronization therapy
Eligibility 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
Sites / Locations
- Foothills Hospital
- London Health Sciences
- Quebec Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Targeted LV lead placement
Usual LV lead placement
Outcomes
Primary Outcome Measures
Change in end systolic volume plus reduction in symptoms
Secondary Outcome Measures
Minnesota Living with Heart Failure score.
Short form thirty six score.
Specific Activity Scale score.
New York Heart Association class.
Six minute walk distance.
LV volumes.
N-terminal pro-B-type natriuretic peptide.
Mortality
Hospitalization
Full Information
NCT ID
NCT00399594
First Posted
November 13, 2006
Last Updated
November 20, 2015
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Medtronic, Hoffmann-La Roche, Cambridge Heart Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00399594
Brief Title
Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
Acronym
INCREMENTAL
Official Title
Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Medtronic, Hoffmann-La Roche, Cambridge Heart Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Cardiac Pacing, Artificial, Defibrillators
Keywords
Mechanical dyssynchrony, Biventricular pacing, Cardiac resynchronization therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Targeted LV lead placement
Arm Title
B
Arm Type
Active Comparator
Arm Description
Usual LV lead placement
Intervention Type
Procedure
Intervention Name(s)
A
Intervention Description
LV lead placement in region of latest mechanical velocity (tissue doppler)
Intervention Type
Procedure
Intervention Name(s)
B
Intervention Description
LV lead placement in standard (lateral / posterolateral) position.
Primary Outcome Measure Information:
Title
Change in end systolic volume plus reduction in symptoms
Time Frame
over 12 months
Secondary Outcome Measure Information:
Title
Minnesota Living with Heart Failure score.
Time Frame
Change over 12 months
Title
Short form thirty six score.
Time Frame
Change over 12 months
Title
Specific Activity Scale score.
Time Frame
Change over 12 months
Title
New York Heart Association class.
Time Frame
Change over 12 months
Title
Six minute walk distance.
Time Frame
Change over 12 months
Title
LV volumes.
Time Frame
Change over 12 months
Title
N-terminal pro-B-type natriuretic peptide.
Time Frame
Change over 12 months
Title
Mortality
Time Frame
Study duration
Title
Hospitalization
Time Frame
Study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek V Exner, MD, MPH
Organizational Affiliation
Libin Cardiovascular Institute of Alberta, University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
Country
Canada
Facility Name
Quebec Heart Institute
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
12. IPD Sharing Statement
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Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
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