Heart Failure4296NCT00927251
Model 4296 Left Ventricular (LV) Lead Study
A study testing Pacing Lead (Model 4296 LV Lead) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 8 countries.
Trial summary
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacing Lead (Model 4296 LV Lead)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 16 sitesin 8 countries
- Study dates
- Jun 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
- On optimal medical treatment according to investigator opinion
- Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
- Patient consent
- Geographically stable
Who cannot join
- Left Ventricular (LV) lead implant attempt in last 30 days
- Unstable angina or acute myocardial infarction (MI) in past 30 days
- Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
- Contraindicated for transvenous pacing
- Heart transplant
- Contraindicated for less than 1 milligram (mg) dexamethasone acetate
Show all 9Show fewer
- Enrolled or intends to participate in concurrent drug and/or device study which would confound results
- Life expectancy shorter than duration of the study
- Unable to tolerate urgent thoracotomy
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
Germany5 sites
Study site
Bad Rothenfelde
Study site
Essen
Study site
Heidelberg
Study site
Lüdenscheid
Study site
Ulm
About this study
Official title: Model 4296 Left Ventricular Lead Study
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.
Read the detailed description
This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.
- Conditions
- Heart Failure
- Being tested
- Pacing Lead (Model 4296 LV Lead)
- Keywords
- heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing Lead (Model 4296 LV Lead)Device
Implant and follow-up of study device
| Study group | Role | What they receive |
|---|---|---|
| Model 4296 LV Lead | Experimental | Non-randomized study Receives: Device: Pacing Lead (Model 4296 LV Lead) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Left Ventricular (LV)Lead Related Complications
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
Measured: Implant to one-month post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Biffi, M.D., Principal investigator, Policlinico S. Orsola-Malpighi in Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927251
- Sponsor's protocol ID
- 4296
- Acronym
- 4296
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2009
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model 4296 Left Ventricular Lead Study
- ClinicalTrials.gov ID
- NCT00927251
- Acronym / sponsor ID
- 4296 / 4296
- Conditions
- Heart Failure
- Keywords
- heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 29 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.
Detailed description
This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Model 4296 LV Lead | Experimental | Device: Pacing Lead (Model 4296 LV Lead)Non-randomized study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
- On optimal medical treatment according to investigator opinion
- Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
- Patient consent
- Geographically stable
Key exclusion criteria (9 listed)
- Left Ventricular (LV) lead implant attempt in last 30 days
- Unstable angina or acute myocardial infarction (MI) in past 30 days
- Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
- Contraindicated for transvenous pacing
- Heart transplant
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 |
|---|---|---|
| Pacing Lead (Model 4296 LV Lead)Implant and follow-up of study device | Device | Model 4296 LV Lead |
Primary outcome
Number of Participants With Left Ventricular (LV)Lead Related Complications
Time frame: Implant to one-month post implant
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
M. Biffi, M.D. principal investigator
Policlinico S. Orsola-Malpighi in Bologna, Italy
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing Lead (Model 4296 LV Lead) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 8 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Italy, Austria, Netherlands, Finland and 3 more countries. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Left Ventricular (LV)Lead Related Complications (time frame: Implant to one-month post implant). 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 18 Feb 2019.