|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00370526 |
|
Date of registration:
|
29/08/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
|
|
Scientific title:
|
HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation |
|
Date of first enrolment:
|
February 2007 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00370526 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Canada
|
Italy
|
United States
| | | | | |
|
Contacts
|
|
Name:
|
Carlo Pappone, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
San Raffaele University Hospital |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure, Congestive
|
|
Intervention(s)
|
|
Procedure: Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
|
|
Primary Outcome(s)
|
|
Reduction in end systolic volume (ESV)
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
New York Heart Association (NYHA) Class
[Time Frame: 6 months]
|
|
6 minute walk
[Time Frame: 6 months]
|
|
Cardiac-related mortality
[Time Frame: 6 months]
|
|
HF-related hospitalizations
[Time Frame: 6 months]
|
|
Quality of life (QoL)
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
PM-CLIN 008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|