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HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study

NCT00370526 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-01-11

No results posted yet for this study

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.

Conditions

  • Heart Failure, Congestive

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Stereotaxis

    lead INDUSTRY

Principal Investigators

  • Carlo Pappone, MD, PhD · San Raffaele University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-04-30
Completion
2007-12-31

Countries

  • United States
  • Canada
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370526 on ClinicalTrials.gov