Heart FailurePhase 4NCT00964938
Multisite Pacing With a Quadripolar Lead
A Phase 4 study testing Quadripolar LV lead (pacing configurations) in people with Heart Failure, run by Abbott Medical Devices at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing. 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?
- Quadripolar LV lead (pacing configurations)
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Apr 2011
- Phase
- Phase 4
- 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
- Have a scheduled CRT implantation at the participating clinical study site
- Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
- Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations
Who cannot join
- Have persistent or permanent atrial fibrillation
- Have an intrinsic heart rate of <50 beats per minute
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
- Have had a recent CVA or TIA within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
- Have ischemic etiology and are unable to tolerate stress echocardiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients
The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.
- Conditions
- Heart Failure
- Being tested
- Quadripolar LV lead (pacing configurations)
- Keywords
- Hemodynamic response, Cardiac resynchronization therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadripolar LV lead (pacing configurations)Device
Quadripolar LV lead will be used to deliver a combination of pacing configurations
What is being measured
The primary outcome is the main question the study is designed to answer.
dP/dt max
Measured: acute: during implant procedure; 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2011
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- B Thibault, Principal investigator, Montreal Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964938
- Sponsor's protocol ID
- MSLV
- Status last verified
- Feb 2019
- First submitted
- 25 May 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Thibault B, Dubuc M, Khairy P, Guerra PG, Macle L, Rivard L, Roy D, Talajic M, Karst E, Ryu K, Paiement P, Farazi TG. Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace. 2013 Jul;15(7):984-91. doi: 10.1093/europace/eus435. Epub 2013 Feb 27.
PubMed 23447571
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
- Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients
- ClinicalTrials.gov ID
- NCT00964938
- Acronym / sponsor ID
- MSLV
- Conditions
- Heart Failure
- Keywords
- Hemodynamic response, Cardiac resynchronization therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 25 Aug 2009 (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 study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a scheduled CRT implantation at the participating clinical study site
- Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
- Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations
Key exclusion criteria (7 listed)
- Have persistent or permanent atrial fibrillation
- Have an intrinsic heart rate of <50 beats per minute
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
- Have had a recent CVA or TIA within 3 months prior to enrollment
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 |
|---|---|---|
| Quadripolar LV lead (pacing configurations)Quadripolar LV lead will be used to deliver a combination of pacing configurations | Device | – |
Primary outcome
dP/dt max
Time frame: acute: during implant procedure; 1 day
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.
- Derived from this study: PubMed 23447571Thibault B, Dubuc M, Khairy P, Guerra PG, Macle L, Rivard L, Roy D, Talajic M, Karst E, Ryu K, Paiement P, Farazi TG. Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace. 2013 Jul;15(7):984-91. doi: 10.1093/europace/eus435. Epub 2013 Feb 27.
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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.
B Thibault principal investigator
Montreal Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadripolar LV lead (pacing configurations) in people with Heart Failure, run by Abbott Medical Devices at 1 site in Canada.
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 7 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 1 site in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
dP/dt max (time frame: acute: during implant procedure; 1 day). 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 NCT00964938, 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 4 Feb 2019.