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
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure, Congestive Cardiac Pacing, Artificial Defibrillators | Procedure: A Procedure: B | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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). |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | November 2015 |
Arm | Intervention/treatment |
---|---|
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.
|
- Change in end systolic volume plus reduction in symptoms [ Time Frame: over 12 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00399594
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 |
Principal Investigator: | Derek V Exner, MD, MPH | Libin Cardiovascular Institute of Alberta, University of Calgary |
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 |
First Posted: | November 15, 2006 Key Record Dates |
Last Update Posted: | November 24, 2015 |
Last Verified: | November 2015 |
Keywords provided by Dr. Derek Exner, University of Calgary:
Mechanical dyssynchrony Biventricular pacing Cardiac resynchronization therapy |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |