Heart Failure, CongestivePhase 4NCT00370526
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
A Phase 4 study testing Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement in people with Heart Failure, Congestive, run by Stereotaxis at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Northeast Georgia Heart Center, PC
Gainesville, Georgia, 30501
Medical College of Virginia - Virginia Commonwealth University
Richmond, Virginia, 23129
About this study
Official title: HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
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.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Being tested
- Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
- Keywords
- heart failure, resynchronization, CRT, Bi-V pacemaker, LV lead placement, hemodynamic assessment, CRT Outcomes
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in end systolic volume (ESV)
Measured: 6 months
Secondary outcomes (5)
New York Heart Association (NYHA) Class
Measured: 6 months
6 minute walk
Measured: 6 months
Quality of life (QoL)
Measured: 6 months
Cardiac-related mortality
Measured: 6 months
HF-related hospitalizations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startFeb 2007
- Primary completionApr 2007
- Study completionDec 2007
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- Carlo Pappone, MD, PhD, Principal investigator, San Raffaele University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370526
- Sponsor's protocol ID
- PM-CLIN 008
- Status last verified
- Jan 2008
- First submitted
- 29 Aug 2006
- Last updated
- 11 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
- ClinicalTrials.gov ID
- NCT00370526
- Acronym / sponsor ID
- PM-CLIN 008
- Conditions
- Heart Failure, Congestive
- Keywords
- heart failure, resynchronization, CRT, Bi-V pacemaker, LV lead placement, hemodynamic assessment, CRT Outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Feb 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Persistent or chronic atrial fibrillation (AF)
- Hemodynamically unstable or uncontrolled arrhythmias
- Unstable angina
- Aortic valve (AV) insufficiency or stenosis
- Mitral valve (MV) regurgitation > 2+
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement | Procedure or surgery | – |
Primary outcome
Reduction in end systolic volume (ESV)
Time frame: 6 months
5 secondary outcomes
New York Heart Association (NYHA) Class
Time frame: 6 months
6 minute walk
Time frame: 6 months
Quality of life (QoL)
Time frame: 6 months
Cardiac-related mortality
Time frame: 6 months
HF-related hospitalizations
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Pappone, MD, PhD principal investigator
San Raffaele University Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement in people with Heart Failure, Congestive, run by Stereotaxis at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in end systolic volume (ESV) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2008.