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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Country

City, postcode or hospital

16 sites in 8 countries

Germany5 sites

Study site
Bad Rothenfelde
Study site
Essen
Study site
Heidelberg
Study site
Lüdenscheid
Study site
Ulm

Other trials in Germany

Italy3 sites

Study site
Bologna
Study site
Pesaro
Study site
Rovigo

Other trials in Italy

Austria2 sites

Study site
Linz
Study site
Vienna

Other trials in Austria

Netherlands2 sites

Study site
Breda
Study site
Eindhoven

Other trials in Netherlands

Finland1 site

Study site
Oulu

Other trials in Finland

India1 site

Study site
Delhi

Other trials in India

Norway1 site

Study site
Bergen

Other trials in Norway

Slovakia1 site

Study site
Košice

Other trials in Slovakia

About this study

Official title: Model 4296 Left Ventricular Lead Study

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 groups in NCT00927251
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.

Jun 2009Feb 2010

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure

All Heart Failure trials

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.

Detailed description

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

Results posted to the registry on 29 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Model 4296 LV Lead Study	90	82

Primary outcome: Number of Participants With Left Ventricular (LV)Lead Related Complications

Time frame: Implant to one-month post implant. Number. Unit: participants

Measure	Model 4296 LV Lead Study n = 67
Value	1

Population analysed: All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention

Adverse events

Time frame: Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Model 4296 LV Lead Study	16 of 90 (17.8%)	26 of 90 (28.9%)	Not reported

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.

Related trials for Heart Failure

Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure

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?

On the ClinicalTrials.gov record for NCT00927251.

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.