NCT00399594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
4.3 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

3.1 years

First QC Date

November 13, 2006

Last Update Submit

November 20, 2015

Conditions

Heart Failure, CongestiveCardiac Pacing, ArtificialDefibrillators

Keywords

Mechanical dyssynchronyBiventricular pacingCardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

  • Change in end systolic volume plus reduction in symptoms

    over 12 months

Secondary Outcomes (9)

  • Minnesota Living with Heart Failure score.

    Change over 12 months

  • Short form thirty six score.

    Change over 12 months

  • Specific Activity Scale score.

    Change over 12 months

  • New York Heart Association class.

    Change over 12 months

  • Six minute walk distance.

    Change over 12 months

  • +4 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Targeted LV lead placement

Procedure: A

B

ACTIVE COMPARATOR

Usual LV lead placement

Procedure: B

Interventions

APROCEDURE

LV lead placement in region of latest mechanical velocity (tissue doppler)

A
BPROCEDURE

LV lead placement in standard (lateral / posterolateral) position.

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Hospital

Calgary, Alberta, T2N4N1, Canada

Location

London Health Sciences

London, Ontario, Canada

Location

Quebec Heart Institute

Ste-Foy, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Derek V Exner, MD, MPH

    Libin Cardiovascular Institute of Alberta, University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Canada Research Chair in Cardiovascular Clinical Trials

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 15, 2006

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

November 1, 2015

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

CA(3)