Sick Sinus Node SyndromeNCT02301429
Model 20105 Lead Study
A study testing Model 20105 in people with Sick Sinus Node Syndrome, run by Medtronic BRC at 4 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Node Syndrome
- What is being tested?
- Model 20105
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Nov 2014to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
- Subject has signed and dated the study-specific informed consent form
- Subject is 18 years of age or older
- Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study
Who cannot join
- Subject is indicated for BiV pacemaker or ICD
- Subject is pacing dependent
- Subject has a previous Pacemaker System
- Subject has known coronary venous vasculature that is inadequate for lead placement
- Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
- Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
Show all 17Show fewer
- Subject is not in sinus rhythm at implant
- Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
- Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
- Subject is contraindicated for <1mg dexamethasone acetate
- Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
- Subject has a terminal illness and is not expected to survive more than 6 months
- Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
- Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
- Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study
- Subject meets exclusion criteria required by local law.
- Subject is unable to tolerate an urgent thoracotomy
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
- Conditions
- Sick Sinus Node Syndrome
- Being tested
- Model 20105
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model 20105Device
implant and follow-up of study device
| Study group | Role | What they receive |
|---|---|---|
| Model 20105 | Experimental | Receiving the model 20105 Lead Receives: Device: Model 20105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Low implant success rate(46%). For the successfull implants, 3month FU and available electrical data showed an increase in threshold values for the left atrium
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 Sick Sinus Node SyndromeStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301429
- Sponsor's protocol ID
- LV DDD
- Status last verified
- Sep 2016
- First submitted
- 20 Oct 2014
- Last updated
- 26 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model 20105 Lead Study
- ClinicalTrials.gov ID
- NCT02301429
- Acronym / sponsor ID
- LV DDD
- Conditions
- Sick Sinus Node Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low implant success rate(46%). For the successfull implants, 3month FU and available electrical data showed an increase in threshold values for the left atrium
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Posted 26 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Model 20105 | Experimental | Device: Model 20105Receiving the model 20105 Lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
- Subject has signed and dated the study-specific informed consent form
- Subject is 18 years of age or older
- Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study
Key exclusion criteria (17 listed)
- Subject is indicated for BiV pacemaker or ICD
- Subject is pacing dependent
- Subject has a previous Pacemaker System
- Subject has known coronary venous vasculature that is inadequate for lead placement
- Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
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 |
|---|---|---|
| Model 20105implant and follow-up of study device | Device | Model 20105 |
Primary outcome
All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
Time frame: 1 month
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model 20105 in people with Sick Sinus Node Syndrome, run by Medtronic BRC at 4 sites in 4 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 4 inclusion and 17 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 26 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, Netherlands, Singapore, South Africa. 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 26 Oct 2016). 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?
All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. (time frame: 1 month). 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 26 Oct 2016.