Back to resultsHEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
Primary Purpose
Heart Failure, Congestive
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring heart failure, resynchronization, CRT, Bi-V pacemaker, LV lead placement, hemodynamic assessment, CRT Outcomes
Eligibility Criteria
Inclusion Criteria: Ischemic cardiomyopathy Ejection Fraction (EF) <= 35% QRS duration >= 120 msec Standard heart failure (HF) oral medications for at least 1 month Evidence of mechanical dyssynchrony NYHA Class III or IV Exclusion Criteria: Persistent or chronic atrial fibrillation (AF) Hemodynamically unstable or uncontrolled arrhythmias Unstable angina Aortic valve (AV) insufficiency or stenosis Mitral valve (MV) regurgitation > 2+ Active infection Contraindications for heparin Dependence on atrial pacing
Sites / Locations
- Northeast Georgia Heart Center, PC
- Medical University of South Carolina
- Medical College of Virginia - Virginia Commonwealth University
- University of Ottawa Heart Institute
- San Raffaele University Hospital
Outcomes
Primary Outcome Measures
Reduction in end systolic volume (ESV)
Secondary Outcome Measures
New York Heart Association (NYHA) Class
6 minute walk
Quality of life (QoL)
Cardiac-related mortality
HF-related hospitalizations
Full Information
NCT ID
NCT00370526
First Posted
August 29, 2006
Last Updated
January 2, 2008
Sponsor
Stereotaxis
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00370526
Brief Title
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
Official Title
HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stereotaxis
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.
Detailed Description
Baseline information will be obtained including QoL, 6-minute walk, and echo measurements. The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetically-placed LV lead. The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms. Adverse events will also be recorded during the follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
heart failure, resynchronization, CRT, Bi-V pacemaker, LV lead placement, hemodynamic assessment, CRT Outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
Primary Outcome Measure Information:
Title
Reduction in end systolic volume (ESV)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
New York Heart Association (NYHA) Class
Time Frame
6 months
Title
6 minute walk
Time Frame
6 months
Title
Quality of life (QoL)
Time Frame
6 months
Title
Cardiac-related mortality
Time Frame
6 months
Title
HF-related hospitalizations
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic cardiomyopathy
Ejection Fraction (EF) <= 35%
QRS duration >= 120 msec
Standard heart failure (HF) oral medications for at least 1 month
Evidence of mechanical dyssynchrony
NYHA Class III or IV
Exclusion Criteria:
Persistent or chronic atrial fibrillation (AF)
Hemodynamically unstable or uncontrolled arrhythmias
Unstable angina
Aortic valve (AV) insufficiency or stenosis
Mitral valve (MV) regurgitation > 2+
Active infection
Contraindications for heparin
Dependence on atrial pacing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD, PhD
Organizational Affiliation
San Raffaele University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeast Georgia Heart Center, PC
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical College of Virginia - Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23129
Country
United States
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
San Raffaele University Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
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