Multi-site Left Ventricular PacingMSLVNCT01044472
Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead
An observational study of Multi-site Left Ventricular Pacing, run by Abbott Medical Devices at 10 sites in 2 countries.
Trial summary
The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-site Left Ventricular Pacing
- How many people
- 61 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2010to May 2010
- Phase
- Observational
- 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
Study population: Patients with standard CRT-D indications
Who may be able to join
- Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system.
- Patients have signed an informed consent form indicating their willingness to participate to this study.
Who cannot join
- Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
- Patients with second or third degree AV Block
- Patients with intrinsic atrial rhythm < 40 bpm
- Patients with a previously implanted left ventricular pacing lead.
- Patients who are pregnant.
- Patients currently participating in a clinical investigation that includes an active treatment arm.
- Patients under 18 years of age.
- Patients with a life expectancy of less then 6 months.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany7 sites
Herzzentrum
Bad Krozingen
Kerckhoff - Klinik
Bad Nauheim
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen
Schüchtermannklinik
Bad Rothenfelde
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt
Städt. Klinikum
Ludwigshafen
Klinikum Rosenheim
Rosenheim
United Kingdom3 sites
Russells Hall
Dudley
Liverpool Heart and Chest Hospital
Liverpool
St Thomas
London
About this study
The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.
Read the detailed description
To evaluate the hemodynamic impact of different pacing MSLV configurations.
- Conditions
- Multi-site Left Ventricular Pacing
- Keywords
- CRT-D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-site Left Ventricular PacingStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044472
- Sponsor's protocol ID
- CR-09-048-EU-HF
- Acronym
- MSLV
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead
- ClinicalTrials.gov ID
- NCT01044472
- Acronym / sponsor ID
- MSLV / CR-09-048-EU-HF
- Conditions
- Multi-site Left Ventricular Pacing
- Keywords
- CRT-D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Jan 2010 (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 purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.
Detailed description
To evaluate the hemodynamic impact of different pacing MSLV configurations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard CRT-D indications
Key inclusion criteria (2 listed)
- Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system.
- Patients have signed an informed consent form indicating their willingness to participate to this study.
Key exclusion criteria (8 listed)
- Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
- Patients with second or third degree AV Block
- Patients with intrinsic atrial rhythm < 40 bpm
- Patients with a previously implanted left ventricular pacing lead.
- Patients who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Feb 2019.
- Individual participant dataSharing planned: No
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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-site Left Ventricular Pacing, run by Abbott Medical Devices at 10 sites in 2 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 2 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: finished, as of the sponsor's last update on 4 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 10 sites in Germany, United Kingdom. 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?
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.
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 4 Feb 2019.