Heart FailurePromote QNCT00990665

Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

A study testing CRT-D and LV lead (Quartet™ lead and Promote Q® device system) in people with Heart Failure, run by Abbott Medical Devices at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system 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?: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 178 participants
Where: 24 sitesUnited States
Study dates: Sep 2009to Jul 2012
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

Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
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

Who cannot join

Have had a recent CVA or TIA within three months of enrollment
Have a contraindication for an emergency thoracotomy
Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
Have undergone a cardiac transplantation within 40 days of enrollment
Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment

Show all 11Show fewer

Are currently participating in a clinical investigation that includes an active treatment arm
Are pregnant or planning to become pregnant during the duration of the study
Have a life expectancy of less than 6 months due to any condition
Are less than 18 years of age
Are unable to comply with the follow up schedule

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Piedmont Hospital
Atlanta, Georgia, 30309
University Hospital of Alabama at Birmingham
Birmingham, Alabama, 35233
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Lahey Clinical Medical Center
Burlington, Massachusetts, 01805
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
EMH Regional Medical Center
Elyria, Ohio, 44035
Glendale Memorial Medical Center
Glendale, California, 91204
Lancaster Heart Foundation
Lancaster, Pennsylvania, 17602
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Central Baptist Hospital
Lexington, Kentucky, 40503
Baptist Health Medical Center
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Midwest Heart Foundation
Lombard, Illinois, 60148
University of Southern California
Los Angeles, California, 90033
Methodist University Hospital
Memphis, Tennessee, 38104
Arrhythmia Center for Southern Wisconsin
Milwaukee, Wisconsin, 53215
Morristown Memorial Hospital
Morristown, New Jersey, 07962
ACS Research Group
Mountain View, California, 94040
St. Thomas Hospital
Nashville, Tennessee, 37205
Mount Sinai Hospital
New York, New York, 10029
Orlando Heart Center
Orlando, Florida, 32806
Regional Cardiology Associates
Sacramento, California, 95819
Scripps Green Hospital
San Diego, California, 92037
The Heart and Vascular Institute of Florida - S. Pinellas
St. Petersburg, Florida, 33705

Other trials in United States

About this study

Official title: Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

Conditions: Heart Failure
Being tested: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Keywords: CRT, Heart Failure, LV Leads
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRT-D and LV lead (Quartet™ lead and Promote Q® device system)Device
Promote Q CRT-D and Quartet LV lead

Study groups in NCT00990665
Study group	Role	What they receive
CRT-D and LV lead	Experimental	Not described Receives: Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom From Left Ventricular Lead-Related Complications Through 3 Months
The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Measured: 3 months
Freedom From System-related Complications Through 3 Months
The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
Measured: 3 Months
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).
Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jul 2012

First posted7 Oct 2009 (estimated)
Study startSep 2009
Primary completionSep 2010
Study completionJul 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.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00990665
Sponsor's protocol ID: 60024498/E
Acronym: Promote Q
Status last verified: Feb 2019
First submitted: 6 Oct 2009
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.
PubMed 23339555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
ClinicalTrials.gov ID: NCT00990665
Acronym / sponsor ID: Promote Q / 60024498/E
Conditions: Heart Failure
Keywords: CRT, Heart Failure, LV Leads
Study type: Interventional
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Sep 2010 (actual)
Study completion: Jul 2012 (actual)
First posted: 7 Oct 2009 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CRT-D and LV lead	Experimental	Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
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

Key exclusion criteria (11 listed)

Have had a recent CVA or TIA within three months of enrollment
Have a contraindication for an emergency thoracotomy
Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
Have undergone a cardiac transplantation within 40 days of 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
CRT-D and LV lead (Quartet™ lead and Promote Q® device system)Promote Q CRT-D and Quartet LV lead	Device	CRT-D and LV lead

Primary outcome

Freedom From Left Ventricular Lead-Related Complications Through 3 Months
Time frame: 3 months
The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Freedom From System-related Complications Through 3 Months
Time frame: 3 Months
The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
Time frame: 3 Months
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CRT-D and LV Lead	178	130

Primary outcome: Freedom From Left Ventricular Lead-Related Complications Through 3 Months

Time frame: 3 months. Number (97.5% Confidence Interval). Unit: percentage probability

Measure	CRT-D and LV Lead n = 178
Value	96 (93 to NA)

Population analysed: Patients implanted with a Promote Q CRT-D device and Quartet LV lead.

Primary outcome: Freedom From System-related Complications Through 3 Months

Time frame: 3 Months. Number (97.5% Confidence Interval). Unit: percentage probability

Measure	CRT-D and LV Lead n = 178
Value	92 (88 to NA)

Population analysed: Participants implanted with a Promote Q CRT-D device and Quartet LV lead.

Primary outcome: The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.

Time frame: 3 Months. Number (97.5% Confidence Interval). Unit: percentage of participants

Measure	Patients Per Statistical Analysis Plan n = 178	Patients Per Complete Case Analysis n = 162
Value	79.2 (72.5 to NA)	83.3 (76.7 to NA)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRT-D and LV Lead	0 of 178 (0%)	76 of 178 (42.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23339555Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.

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
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Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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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.

Gery Tomassoni, MD study chair

Central Baptist Hospital

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CRT-D and LV lead (Quartet™ lead and Promote Q® device system) in people with Heart Failure, run by Abbott Medical Devices at 24 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 3 inclusion and 11 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 27 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 24 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 27 Feb 2019). 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?

Freedom From Left Ventricular Lead-Related Complications Through 3 Months (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT00990665, 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 27 Feb 2019.