Heart FailureNCT00763698
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
A study testing QuickFlex Micro Model 1258T Left Heart Lead in people with Heart Failure, run by Abbott Medical Devices at 13 sites in United States.
Trial summary
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. 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?
- QuickFlex Micro Model 1258T Left Heart Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2008to May 2010
- 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 for CRT-D system
Who cannot join
- Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- Previous left ventricular (LV) lead implant
- Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University Hospital-University of Alabama at Birmingham
Birmingham, Alabama, 35233
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
St. John Hospital and Medical Center
Detroit, Michigan, 48236
EMH Regional Medical Center
Elyria, Ohio, 44035
Glendale Memorial Hospital and Medical Center
Glendale, California, 91204
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Central Baptist Hospital
Lexington, Kentucky, 40503
Arkansas Cardiology
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Midwest Heart Foundation
Lombard, Illinois, 60148
St. Thomas Hospital
Nashville, Tennessee, 37205
St. Francis Hospital
Roslyn, New York, 11576
Regional Cardiology Associates
Sacramento, California, 95819
About this study
Official title: QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.
Read the detailed description
The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.
Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.
- Conditions
- Heart Failure
- Being tested
- QuickFlex Micro Model 1258T Left Heart Lead
- Keywords
- Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure, ICD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuickFlex Micro Model 1258T Left Heart LeadDevice
Also called Model 1258T left heart pacing lead
Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
| Study group | Role | What they receive |
|---|---|---|
| QuickFlex micro 1258T left heart lead | Experimental | Not described Receives: Device: QuickFlex Micro Model 1258T Left Heart Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Left Ventricular Lead-related Complications
A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
Measured: 3 months
Percentage of Successful Left Ventricular Lead Implants
Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
Measured: 3 months
Left Ventricular Bipolar Pacing Capture Threshold (Volts)
The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.
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 posted1 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionMay 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamara Shipman, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763698
- Sponsor's protocol ID
- CRD 435
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2008
- Last updated
- 19 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 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuickFlex Micro Model 1258T Left Heart Pacing Lead
- ClinicalTrials.gov ID
- NCT00763698
- Acronym / sponsor ID
- CRD 435
- Conditions
- Heart Failure
- Keywords
- Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure, ICD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Posted 4 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.
Detailed description
The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.
Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QuickFlex micro 1258T left heart lead | Experimental | Device: QuickFlex Micro Model 1258T Left Heart Lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Approved indication for CRT-D system
Key exclusion criteria (3 listed)
- Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- Previous left ventricular (LV) lead implant
- Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days 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 |
|---|---|---|
| QuickFlex Micro Model 1258T Left Heart LeadAlso: Model 1258T left heart pacing leadImplantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system. | Device | QuickFlex micro 1258T left heart lead |
Primary outcome
Freedom From Left Ventricular Lead-related Complications
Time frame: 3 months
A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
Percentage of Successful Left Ventricular Lead Implants
Time frame: 3 months
Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
Left Ventricular Bipolar Pacing Capture Threshold (Volts)
Time frame: 3 months
The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Tamara Shipman study director
Abbott Medical Devices
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuickFlex Micro Model 1258T Left Heart Lead in people with Heart Failure, run by Abbott Medical Devices at 13 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 1 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 19 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 13 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 4 Nov 2011). 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 (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?
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 19 Feb 2019.