Heart FailureNCT02548455
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
A study testing Quartet 1457Q LV Lead in people with Heart Failure, run by Abbott Medical Devices at 30 sites in United States.
Trial summary
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy. 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?
- Quartet 1457Q LV Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 30 sitesUnited States
- Study dates
- 27 Oct 2015to 21 Mar 2017
- 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
- Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
- " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
- Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
- Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Who cannot join
- Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
- Are pregnant or planning pregnancy in the next 6 months
- Have a life expectancy of less than 24 months due to any condition
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Emory University Hospital
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Erlanger Medical Center
Chattanooga, Tennessee, 37403
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Missouri Heart Center
Columbia, Missouri, 65201
North Georgia Heart Foundation
Gainesville, Georgia, 30501
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Greenville Health System
Greenville, South Carolina, 29605
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, 08035
Heart Center Research
Huntsville, Alabama, 35801
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401
Scripps Health
La Jolla, California, 92037
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, 48912
Central Baptist Hospital
Lexington, Kentucky, 40503
St. Mary's Hospital
Madison, Wisconsin, 53715
Catholic Medical Center
Manchester, New Hampshire, 03102
Premier Cardiology, Inc.
Newport Beach, California, 92663
Munroe Regional Medical Center
Ocala, Florida, 34471
One Health Cardiology
Owensboro, Kentucky, 42304
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85013
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840
Swedish Medical Center - Heart & Vascular
Seattle, Washington, 98122
Stanford University Hospital
Stanford, California, 94305
Tallahassee Research Institute
Tallahassee, Florida, 32308
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, 74104
Iowa Heart Center
West Des Moines, Iowa, 50266
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
Read the detailed description
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.
A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.
All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
- Conditions
- Heart Failure
- Being tested
- Quartet 1457Q LV 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.
Quartet 1457Q LV LeadDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects implanted with the Quartet 1457Q LV lead Receives: Device: Quartet 1457Q LV Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Free From LV Lead-related Complications Through 3 Months
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start27 Oct 2015
- Primary completion19 Aug 2016
- Study completion21 Mar 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Delurgio, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548455
- Sponsor's protocol ID
- CRD 616
- Status last verified
- Jan 2019
- First submitted
- 10 Sep 2015
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
- A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
- ClinicalTrials.gov ID
- NCT02548455
- Acronym / sponsor ID
- CRD 616
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 19 Aug 2016 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Posted 8 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
Detailed description
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.
A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.
All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Quartet 1457Q LV LeadSubjects implanted with the Quartet 1457Q LV 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)
- Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
- " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
- Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
- Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Key exclusion criteria (5 listed)
- Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
- Are pregnant or planning pregnancy in the next 6 months
- Have a life expectancy of less than 24 months due to any condition
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 |
|---|---|---|
| Quartet 1457Q LV Lead | Device | Treatment |
Primary outcome
Number of Patients Free From LV Lead-related Complications Through 3 Months
Time frame: 3 months
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
David Delurgio, MD study chair
Emory University
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quartet 1457Q LV Lead in people with Heart Failure, run by Abbott Medical Devices at 30 sites in United States.
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 5 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 30 sites in United States. 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 8 May 2018). 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 Free From LV Lead-related Complications Through 3 Months (time frame: 3 months). 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 4 Feb 2019.