NCT00370526

TerminatedPhase 4

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

Stereotaxis Source

Stereotaxis

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

PM-CLIN 008

Study Type

interventional

Estimated enrollment

100

Locations

3 countries

Sites

5

Timeline

Study Start

February 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2007

Actual (reported)

Study Completion

December 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 100 participants
Study completion date: December 2007
Actual (reported)
Listed locations: 3 countries · 5 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 29, 2006
Actual (reported)
First Posted
August 31, 2006
Actual (reported)
Study Start
February 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2007
Actual (reported)
Study Completion
December 2007
Actual (reported)

Last Updated: January 11, 2008
Status Verified: January 2008
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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%

Sponsors & Collaborators

Stereotaxis
Industrylead
Medtronic
Industrycollaborator

Study Sites (5)

Northeast Georgia Heart Center, PC

Gainesville, Georgia, 30501, United States

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Medical College of Virginia - Virginia Commonwealth University

Richmond, Virginia, 23129, United States

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

San Raffaele University Hospital

Milan, 20132, Italy

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 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2007

Actual (reported)

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Phase 4Unknown

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Phase 4Unknown

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Phase 4Terminated

NCT02871466

Stem Cells Therapy in Advanced Heart Failure

Phase 4Unknown

NCT00233480

Statin Therapy in Heart Failure: Potential Mechanisms of Benefit

Phase 4Completed

NCT00013221

Exercise Effect on Aerobic Capacity and QOL in Heart Failure

Phase 4Completed

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.

Study Completion

December 2007

Actual (reported)

Last Updated

January 11, 2008

Record last verified: 2008-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00370526
Data provider: ClinicalTrials.gov
Source updated: 2008-01-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:06 UTC

Locations

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

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations