NCT00370526

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_4

Geographic Reach
3 countries

5 active sites

Status
terminated

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

August 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

Enrollment Period

2 months

First QC Date

August 29, 2006

Last Update Submit

January 2, 2008

Conditions

Heart Failure, Congestive

Keywords

heart failureresynchronizationCRTBi-V pacemakerLV lead placementhemodynamic assessmentCRT Outcomes

Outcome Measures

Primary Outcomes (1)

  • Reduction in end systolic volume (ESV)

    6 months

Secondary Outcomes (5)

  • New York Heart Association (NYHA) Class

    6 months

  • 6 minute walk

    6 months

  • Quality of life (QoL)

    6 months

  • Cardiac-related mortality

    6 months

  • HF-related hospitalizations

    6 months

Interventions

Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placementPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northeast Georgia Heart Center, PC

Gainesville, Georgia, 30501, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Medical College of Virginia - Virginia Commonwealth University

Richmond, Virginia, 23129, United States

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

San Raffaele University Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carlo Pappone, MD, PhD

    San Raffaele University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2006

First Posted

August 31, 2006

Study Start

February 1, 2007

Primary Completion

April 1, 2007

Study Completion

December 1, 2007

Last Updated

January 11, 2008

Record last verified: 2008-01

Locations

CA(1)IT(1)US(3)