QuickFlex Micro Left Ventricular Lead Post Approval Study

An observational study of Heart Failure, run by Abbott Medical Devices at 77 sites in United States.

Completed

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

Trial summary

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) 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?: Implantation of a QuickFlex® μ Model 1258T LV Lead
Type of treatment: Medical device
How many people: 1,930 participants
Where: 77 sitesUnited States
Study dates: Sep 2010to Sep 2017
Phase: Observational
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

Study population: Patients with an approved indication for implantation of a CRT-D system

Who may be able to join

Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Who cannot join

Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Have a life expectancy of less than 5 years due to any condition
Be less than 18 years of age

Trial locations and contacts

77 sites in 1 country.

City, postcode or hospital

77 sites in 1 country

United States77 sites

Alaska Heart Institute
Anchorage, Alaska, 99508
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, 48197
King's Daughters Medical Center
Ashland, Kentucky, 41101
Athens Regional Medical Center
Athens, Georgia, 30306
St. Joseph's Hospital
Atlanta, Georgia, 30045
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, 15009
HeartPlace
Bedford, Texas, 76021
Cardiovascular Associates P.C.
Birmingham, Alabama, 35213
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, 17011
Medical University of South Carolina
Charleston, South Carolina, 29425
Charleston Area Medical Center
Charleston, West Virginia, 25304
Cardiovascular Associates Ltd
Chesapeake, Virginia, 23320
Parkview Research Center
Fort Wayne, Indiana, 46805
Glendale Memorial Hospital and Medical Center
Glendale, California, 91206
LeBauer HeartCare
Greensboro, North Carolina, 27401
Heart Center Research, LLC.
Huntsville, Alabama, 35801
Jackson Heart Clinic
Jackson, Mississippi, 39216
Shands Jacksonville
Jacksonville, Florida, 32209
Cardiology Consultants
Johnson City, Tennessee, 37601
Mid-America Cardiology Associates, PC
Kansas City, Kansas, 66160
Primed Cardiology/Kettering Medical Center Network
Kettering, Ohio, 45429
Naushad Shaik, MD
Kissimmee, Florida, 32804
Thoracic Cardio Healthcare Found. (aka Sparrow Research)
Lansing, Michigan, 48912
Central Baptist Hospital
Lexington, Kentucky, 40503
Arkansas Cardiology
Little Rock, Arkansas, 72205
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Norton Bluegrass Heart Specialists
Louisville, Kentucky, 40217
St. Mary's Hospital
Madison, Wisconsin, 53715
Methodist University Hospital
Memphis, Tennessee, 38104
The Stern Cardiovascular Foundation
Memphis, Tennessee, 38120
MidMichigan Physicians Group
Midland, Michigan, 48640
Cardiac Rhythm Specialists, S.C.
Milwaukee, Wisconsin, 53211
Lenox Hill Hospital
New York, New York, 10028
Christiana Hospital
Newark, Delaware, 19713
The Heart Group
Newburgh, Indiana, 47630
Munroe Regional Medical Center
Ocala, Florida, 34471
McKay-Dee Heart Services
Ogden, Utah, 84403
Heart Consultants P.C.
Omaha, Nebraska, 68122
Usman R. Siddiqui, MD
Orlando, Florida, 32803
Orlando Heart Center
Orlando, Florida, 32806
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85013
Advanced Heart Care
Plano, Texas, 75093
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240
Providence Heart and Vascular Institute
Portland, Oregon, 97220
Brevard Cardiovascular Research Associates, Inc.
Rockledge, Florida, 32955
Redmond Regional Medical Center
Rome, Georgia, 30165
Regional Cardiology Associates
Sacramento, California, 95819
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, 21804
University of Utah Hospital
Salt Lake City, Utah, 84132
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
Brooke Army Medical Center
San Antonio, Texas, 78234
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92118
Claudio Bonometti MD, Inc
Santa Barbara, California, 93105
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85252
Northwest Cardiology
Springdale, Arkansas, 72764
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Regional Cardiovascular Medical Center
Steubenville, Ohio, 43953
University of South Florida, Cardiovascular Services
Tampa, Florida, 33606
The Toledo Hospital
Toledo, Ohio, 43615
Toledo Clinic
Toledo, Ohio, 43623
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, 90502
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Iowa Heart Center
West Des Moines, Iowa, 50266
New Jersey Cardiology Associates
West Orange, New Jersey, 07052
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, 27157
WellSpan Health
York, Pennsylvania, 17405
St. Elizabeth Health Center
Youngstown, Ohio, 44505

Other trials in United States

About this study

Official title: QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

Read the detailed description

The primary endpoints of the study are:

Freedom from LV lead-related complications at 5 years
LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years

Conditions: Heart Failure
Being tested: Implantation of a QuickFlex® μ Model 1258T LV Lead
Keywords: Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure
Medical subject headings: Heart Failure

What participants receive

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

Implantation of a QuickFlex® μ Model 1258T LV LeadDevice
Also called LV pacing lead
Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead

What is being measured

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

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Measured: 5 years
Left Ventricular Bipolar Pacing Capture Threshold
Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up
Measured: 5 years

Timeline

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

Sep 2010Sep 2017

First posted11 Aug 2010 (estimated)
Study startSep 2010
Primary completionSep 2017
Study completionSep 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,930 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01179477
Sponsor's protocol ID: CRD561
Status last verified: Jul 2019
First submitted: 9 Aug 2010
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
ClinicalTrials.gov ID: NCT01179477
Acronym / sponsor ID: CRD561
Conditions: Heart Failure
Keywords: Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure
Study type: Observational
Recruitment status: Completed
Enrolment: 1,930 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Sep 2010 (actual)
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 11 Aug 2010 (estimated)
Results: Posted 12 Aug 2019

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 multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

Detailed description

The primary endpoints of the study are:

Freedom from LV lead-related complications at 5 years
LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years

Study design

Observational model: Case only
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 an approved indication for implantation of a CRT-D system

Key inclusion criteria (2 listed)

Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Key exclusion criteria (3 listed)

Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Have a life expectancy of less than 5 years due to any condition
Be less than 18 years of age

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
Implantation of a QuickFlex® μ Model 1258T LV LeadAlso: LV pacing leadImplantation of a QuickFlex® μ Model 1258T LV Pacing Lead	Device	–

Primary outcome

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
Time frame: 5 years
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Left Ventricular Bipolar Pacing Capture Threshold
Time frame: 5 years
Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up

Results and safety

Results posted to the registry on 12 Aug 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
Subjects Implanted With a New QuickFlex μ Lead	1,930	843

Primary outcome: Percent of Participants Alive and Without a Left Ventricular Lead-related Complication

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Subjects Implanted With a New QuickFlex μ Lead n = 1984
Value	1902

Population analysed: The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects.

Primary outcome: Left Ventricular Bipolar Pacing Capture Threshold

Time frame: 5 years. Mean (Standard Deviation). Unit: Volts

Measure	Subjects Implanted With a New QuickFlex μ Lead n = 774
Value	2.04 (1.6)

Population analysed: Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data.

Adverse events

Time frame: Complications and observations post implant through 5 years. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Implanted With a New QuickFlex μ Lead	258 of 1,930 (13.4%)	512 of 1,930 (26.5%)	542 of 1,930

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure

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.

Clay Cohorn study director

Abbott Medical Devices

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

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Abbott Medical Devices at 77 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 2 inclusion and 3 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 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 12 Aug 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?

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication (time frame: 5 years). The study lists 2 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 NCT01179477.

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 12 Aug 2019.