Heart FailureNCT03099655
Attain Stability™ Quad Clinical Study
A study testing Attain Stability Quad Left Ventricular Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 50 sites in 10 countries.
Trial summary
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798). 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?
- Attain Stability Quad Left Ventricular Pacing Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 50 sitesin 10 countries
- Study dates
- 7 Jul 2017to 31 May 2019
- 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
- Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines)
- Patient (or legally authorized representative) has signed and dated the study-specific Informed Consent Form
- Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
- Patient is expected to remain available for follow-up visits
Who cannot join
- Patient has had a previous unsuccessful LV lead implant attempt
- Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial)
- Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead
- Patient has known coronary venous vasculature that is inadequate for lead placement
- Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
- Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 90 days
Show all 14Show fewer
- Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
- Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
- Patient has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
- Patient is contraindicated for <1mg dexamethasone acetate
- Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
- Patient has a terminal illness and is not expected to survive more than six months
- Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
- Patient is unable to tolerate an urgent thoracotomy
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
United States35 sites
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Emory University Hospital
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30309
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Carolinas Medical Center
Charlotte, North Carolina, 28203
The Lindner Research Center
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor Research Institute (Plano TX)
Dallas, Texas, 75226
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
Sequoia Hospital
East Palo Alto, California, 94062
Hartford Hospital
Hartford, Connecticut, 06102
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
Houston, Texas, 77030
Baptist Heart Specialists Pavilion Office
Jacksonville, Florida, 32216
DLP Marquette Physicians Practices Inc
Marquette, Michigan, 49855
Sutherland Cardiology Clinic
Memphis, Tennessee, 38103
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Centennial Heart Cardiovascular Consultants L
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06520
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, 85006
The Valley Hospital
Ridgewood, New Jersey, 07450
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
HealthPartners Institute (Saint Louis Park MN)
Saint Louis Park, Minnesota, 55426
Delmarva Heart Research Foundation Inc
Salisbury, Maryland, 21804
Kootenai Heart Clinics Northwest
Spokane, Washington, 99204
Prairie Education & Research Cooperative (Springfield IL)
Springfield, Illinois, 62701
Torrance Memorial Medical Center
Torrance, California, 90505
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Iowa Heart Center (West Des Moines IA)
West Des Moines, Iowa, 50266
Canada4 sites
University of Calgary
Calgary, T2N 4N1
London Health Sciences Centre - University Campus
London, N6A 5A5
Southlake Regional Health Centre
Newmarket, L3Y 8C3
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, G1V 4G5
Germany2 sites
Klinik für Herzchirurgie Karlsruhe
Karlsruhe, 76185
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Lüdenscheid, 58515
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Isala Zwolle
Zwolle, 8011 JW
Spain2 sites
Hospital Universitario Ramón y Cajal
Madrid, 28050
Hospital Clínico Universitario de Valladolid
Valladolid, 47006
Italy1 site
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
Pisa, 56100
Malaysia1 site
Institut Jantung Negara - National Heart Institute
Kuala Lumpur, 50400
About this study
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
Read the detailed description
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, investigational Device Exemption (IDE), interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary efficacy endpoints.
All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.
- Conditions
- Heart Failure
- Being tested
- Attain Stability Quad Left Ventricular Pacing Lead
- Keywords
- Heart Failure, Cardiac Pacing, Cardiac Resynchronization Therapy, Left Ventricular 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.
Attain Stability Quad Left Ventricular Pacing LeadDevice
Also called 4798 Lead
cardiac stimulation
| Study group | Role | What they receive |
|---|---|---|
| Attain Stability Quad Lead | Experimental | Attain Stability Quad Lead (Model 4798) - Single arm study. Receives: Device: Attain Stability Quad Left Ventricular Pacing Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead Complication-free Rate at 6 Months
Subjects free of Model 4798 lead-related complications at 6 months post-implant
-Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, "An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention". Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.
Measured: Implant to 6 months post-implant
Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V.
-Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Measured: 6 months post-implant
Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy.
-Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Measured: 6 months post-implant
Secondary outcomes (5)
Implant Success
Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
Measured: During procedure
Implant Duration
Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure.
Measured: During procedure
LV Pacing Capture Threshold (PCT) at 6 Months
Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit.
Measured: Implant to 6 months post-implant
LV Impedance at 6 Months
Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject
Measured: Implant to 6 months
Post Implant Lead Failure Rate
Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure
Measured: Implant to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start7 Jul 2017
- Primary completion2 Aug 2018
- Study completion31 May 2019
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.
- 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
- Model description
- The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV lead. This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead (Model 20066/4796) (available outside of the United States).
- Masking
- None (open label)
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Crossley III, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099655
- Sponsor's protocol ID
- Attain Stability Quad
- Status last verified
- Dec 2019
- First submitted
- 14 Mar 2017
- Last updated
- 9 Jan 2020
- 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 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attain Stability™ Quad Clinical Study
- ClinicalTrials.gov ID
- NCT03099655
- Acronym / sponsor ID
- Attain Stability Quad
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac Pacing, Cardiac Resynchronization Therapy, Left Ventricular Lead
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 9 Jan 2020
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 study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
Detailed description
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, investigational Device Exemption (IDE), interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary efficacy endpoints.
All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV lead. This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead (Model 20066/4796) (available outside of the United States).
| Arm | Type | Receives |
|---|---|---|
| Attain Stability Quad Lead | Experimental | Device: Attain Stability Quad Left Ventricular Pacing LeadAttain Stability Quad Lead (Model 4798) - Single arm study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines)
- Patient (or legally authorized representative) has signed and dated the study-specific Informed Consent Form
- Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
- Patient is expected to remain available for follow-up visits
Key exclusion criteria (14 listed)
- Patient has had a previous unsuccessful LV lead implant attempt
- Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial)
- Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead
- Patient has known coronary venous vasculature that is inadequate for lead placement
- Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
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 |
|---|---|---|
| Attain Stability Quad Left Ventricular Pacing LeadAlso: 4798 Leadcardiac stimulation | Device | Attain Stability Quad Lead |
Primary outcome
Lead Complication-free Rate at 6 Months
Time frame: Implant to 6 months post-implant
Subjects free of Model 4798 lead-related complications at 6 months post-implant -Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, "An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention". Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.
Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
Time frame: 6 months post-implant
The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V. -Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
Time frame: 6 months post-implant
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy. -Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
5 secondary outcomes
Implant Success
Time frame: During procedure
Implant Duration
Time frame: During procedure
LV Pacing Capture Threshold (PCT) at 6 Months
Time frame: Implant to 6 months post-implant
LV Impedance at 6 Months
Time frame: Implant to 6 months
Post Implant Lead Failure Rate
Time frame: Implant to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
George Crossley III, MD principal investigator
Vanderbilt University Medical Center
50 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attain Stability Quad Left Ventricular Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 50 sites in 10 countries.
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 14 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada, Germany, Netherlands, Spain and 5 more countries. 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 9 Jan 2020). 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?
Lead Complication-free Rate at 6 Months (time frame: Implant to 6 months post-implant). 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 9 Jan 2020.