Heart FailurePhase 4QUARTONCT01295840
Quartet Lead and Resynchronization Therapy Options
A Phase 4 study testing Cardiac Resynchronization Therapy Defibrillator in people with Heart Failure, run by Abbott Medical Devices at 1 site in Spain.
Trial summary
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead. 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?
- Cardiac Resynchronization Therapy Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Sep 2012
- Phase
- Phase 4
- 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
- Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
- Patients who have provided written informed consent
- Patients who are in sinus rhythm.
- Patients older than 18 years of age.
Who cannot join
- Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
- Patients with valvular disease.
- Patients in functional class New York Heart Association (NYHA) IV
- Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
- Patients whose device has been changed/upgraded.
- Pregnant patients.
- Patients who do not fulfill all the inclusion criteria.
- Patients who are unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response.
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead.
Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.
Read the detailed description
This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device.
This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed.
Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy Defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy DefibrillatorDevice
Also called Promote Q. Model, Promote Quadra™., Quartet®: Tetrapolar left ventricular lead. Model 1458Q.
Cardiac Resynchronization Therapy Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| CRT therapy | No intervention | Cardiac Resynchronization Therapy Defibrillator (CRT-D) Receives: Device: Cardiac Resynchronization Therapy Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.
Measured: Enrollment visit (in the seven days after implantation of the device)
Secondary outcomes (10)
Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors
In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.
The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC.
Measured: At enrollment
Cardiac Output (CO) With Different Configurations at Enrollment
Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.
Measured: Enrollment visit (in the seven days after implantation of the device)
Capture Threshold
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Measured: Enrollment visit (in the seven days after implantation of the device)
Capture Threshold
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Measured: 6 months post-implant
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Measured: Enrollment visit (in the seven days after implantation of the device)
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Measured: At 6 months
Number of Patients With PNS in All Vectors
To calculate the number of patients that exhibit PNS in all traditional vector
Measured: At enrollment
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Measured: At enrollment
Number of Patients With PNS in All Vectors
To calculate the number of patients that exhibit PNS in all traditional vector
Measured: At 6 months
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionSep 2012
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Francisco Javier Alzueta Rodríguez, PhD, Principal investigator, Hospital Clínico Universitario Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295840
- Sponsor's protocol ID
- CR 10-046-SP-HF
- Acronym
- QUARTO
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2011
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response.
- ClinicalTrials.gov ID
- NCT01295840
- Acronym / sponsor ID
- QUARTO / CR 10-046-SP-HF
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Posted 6 Mar 2015
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 Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead.
Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.
Detailed description
This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device.
This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed.
Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT therapy | No intervention | Device: Cardiac Resynchronization Therapy DefibrillatorCardiac Resynchronization Therapy Defibrillator (CRT-D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
- Patients who have provided written informed consent
- Patients who are in sinus rhythm.
- Patients older than 18 years of age.
Key exclusion criteria (8 listed)
- Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
- Patients with valvular disease.
- Patients in functional class New York Heart Association (NYHA) IV
- Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
- Patients whose device has been changed/upgraded.
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 |
|---|---|---|
| Cardiac Resynchronization Therapy DefibrillatorAlso: Promote Q. Model, Promote Quadra™., Quartet®: Tetrapolar left ventricular lead. Model 1458Q.Cardiac Resynchronization Therapy Defibrillator | Device | CRT therapy |
Primary outcome
Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.
Time frame: Enrollment visit (in the seven days after implantation of the device)
10 secondary outcomes
Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors
Time frame: At enrollment
Cardiac Output (CO) With Different Configurations at Enrollment
Time frame: Enrollment visit (in the seven days after implantation of the device)
Capture Threshold
Time frame: Enrollment visit (in the seven days after implantation of the device)
Capture Threshold
Time frame: 6 months post-implant
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Time frame: Enrollment visit (in the seven days after implantation of the device)
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Time frame: At 6 months
Number of Patients With PNS in All Vectors
Time frame: At enrollment
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
Time frame: At enrollment
Number of Patients With PNS in All Vectors
Time frame: At 6 months
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
Time frame: At 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- 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.
Dr. Francisco Javier Alzueta Rodríguez, PhD principal investigator
Hospital Clínico Universitario Virgen de la Victoria
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 Cardiac Resynchronization Therapy Defibrillator in people with Heart Failure, run by Abbott Medical Devices at 1 site in Spain.
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 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 20 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 Spain. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2015). 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 Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode. (time frame: Enrollment visit (in the seven days after implantation of the device)). 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 20 Feb 2019.