Heart FailurePhase 1NCT01365234
Model 20066 Left Ventricular (LV) Lead Study
A Phase 1 study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in 3 countries.
Trial summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacing Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2011to Dec 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
- Patient has signed and dated the study-specific informed consent form
- Patient is 18 years of age or older
- Patient is expected to remain available for follow-ups at the investigational center
- Patient is willing and able to comply with protocol
Who cannot join
- Patient has a previous complete atrial based biventricular CRT system
- Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
- Patient has known coronary venous vasculature that is inadequate for lead placement
- Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
- Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
- Patient has chronic (permanent) atrial arrhythmias
Show all 12Show fewer
- Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
- Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
- Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
- Patient has a terminal illness and is not expected to survive more than three months
- Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc).
- Patient is unable to tolerate an urgent thoracotomy
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
- Conditions
- Heart Failure
- Being tested
- Pacing 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 LeadDevice
Implant and follow up of Model 20066 lead
| Study group | Role | What they receive |
|---|---|---|
| 20066 Lead | Experimental | Non-randomized study. Intervention: Device: Pacing Lead Receives: Device: Pacing Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of implant procedure related and lead-related complications in the first month post-implant
Measured: One Month
Secondary outcomes (14)
Success rate of the Model 20066 lead
Measured: Within 24 hours of procedure initiation
Cannulation time
Measured: Within 24 hours of procedure initiation
Fluoroscopy Time
Measured: Within 24 hours of procedure initiation
Model 20066 Lead Placement Time
Measured: Within 24 hours of procedure initiation
Total Implant Time
Measured: Within 24 hours of procedure initiation
Assessment of Lead Handling Characteristics
Measured: Within 24 hours of procedure initiation
Electrical Performance-Tip Electrode: LV Voltage Threshold
Measured: 12-month
Electrical Performance -Tip Electrode: Sensing
Measured: 12-month
Electrical Performance -Tip Electrode: Pacing Impedance
Measured: 12-month
Electrical Performance -Ring Electrode: LV Voltage Threshold
Measured: 12-month
Electrical Performance -Ring Electrode: Sensing
Measured: Within 24 hours of procedure initiation
Electrical Performance -Ring Electrode: Pacing Impedance
Measured: 12-month
Summarize All Adverse Events
Measured: 12-month
Summarize Final 20066 Lead Position
Measured: Within 24 hours of procedure initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Yee, MD, Principal investigator, London Health Sciences Centre, London, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365234
- Sponsor's protocol ID
- Model 20066
- Status last verified
- Oct 2016
- First submitted
- 25 May 2011
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, Lazeroms M, Hine DS, Marquard KR. Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study. Heart Rhythm. 2014 Jul;11(7):1150-5. doi: 10.1016/j.hrthm.2014.04.020. Epub 2014 May 4.
PubMed 24801899
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model 20066 Left Ventricular (LV) Lead Study
- ClinicalTrials.gov ID
- NCT01365234
- Acronym / sponsor ID
- Model 20066
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Jun 2011 (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.
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20066 Lead | Experimental | Device: Pacing LeadNon-randomized study. Intervention: Device: Pacing Lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
- Patient has signed and dated the study-specific informed consent form
- Patient is 18 years of age or older
- Patient is expected to remain available for follow-ups at the investigational center
- Patient is willing and able to comply with protocol
Key exclusion criteria (12 listed)
- Patient has a previous complete atrial based biventricular CRT system
- Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
- Patient has known coronary venous vasculature that is inadequate for lead placement
- Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
- Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
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 LeadImplant and follow up of Model 20066 lead | Device | 20066 Lead |
Primary outcome
Number of implant procedure related and lead-related complications in the first month post-implant
Time frame: One Month
14 secondary outcomes
Success rate of the Model 20066 lead
Time frame: Within 24 hours of procedure initiation
Cannulation time
Time frame: Within 24 hours of procedure initiation
Fluoroscopy Time
Time frame: Within 24 hours of procedure initiation
Model 20066 Lead Placement Time
Time frame: Within 24 hours of procedure initiation
Total Implant Time
Time frame: Within 24 hours of procedure initiation
Assessment of Lead Handling Characteristics
Time frame: Within 24 hours of procedure initiation
Electrical Performance-Tip Electrode: LV Voltage Threshold
Time frame: 12-month
Electrical Performance -Tip Electrode: Sensing
Time frame: 12-month
Electrical Performance -Tip Electrode: Pacing Impedance
Time frame: 12-month
Electrical Performance -Ring Electrode: LV Voltage Threshold
Time frame: 12-month
Electrical Performance -Ring Electrode: Sensing
Time frame: Within 24 hours of procedure initiation
Electrical Performance -Ring Electrode: Pacing Impedance
Time frame: 12-month
Summarize All Adverse Events
Time frame: 12-month
Summarize Final 20066 Lead Position
Time frame: Within 24 hours of procedure initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Results publication: PubMed 24801899Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, Lazeroms M, Hine DS, Marquard KR. Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study. Heart Rhythm. 2014 Jul;11(7):1150-5. doi: 10.1016/j.hrthm.2014.04.020. Epub 2014 May 4.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
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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.
Raymond Yee, MD principal investigator
London Health Sciences Centre, London, Ontario, Canada
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 4 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 5 inclusion and 12 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Malaysia, Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 implant procedure related and lead-related complications in the first month post-implant (time frame: One Month). 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 NCT01365234, which also lists 1 linked publication.
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 12 Oct 2016; AzTrials last refreshed its copy on 1 Nov 2026.