Attain Stability™ Quad Clinical Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03099655 |
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Recruitment Status :
Completed
First Posted : April 4, 2017
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Device: Attain Stability Quad Left Ventricular Pacing Lead | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 471 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Attain Stability™ Quad Clinical Study |
| Actual Study Start Date : | July 7, 2017 |
| Actual Primary Completion Date : | August 2, 2018 |
| Actual Study Completion Date : | May 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Attain Stability Quad Lead
Attain Stability Quad Lead (Model 4798) - Single arm study.
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Device: Attain Stability Quad Left Ventricular Pacing Lead
cardiac stimulation
Other Name: 4798 Lead |
- 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%.
- Implant Success [ Time Frame: During procedure ]Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
- Implant Duration [ Time Frame: During procedure ]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.
- LV Pacing Capture Threshold (PCT) at 6 Months [ Time Frame: Implant to 6 months post-implant ]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.
- LV Impedance at 6 Months [ Time Frame: Implant to 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
- Post Implant Lead Failure Rate [ Time Frame: Implant to 6 months ]Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099655
Show 50 study locations
| Principal Investigator: | George Crossley III, MD | Vanderbilt University Medical Center |
Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
| Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
| ClinicalTrials.gov Identifier: | NCT03099655 |
| Other Study ID Numbers: |
Attain Stability Quad |
| First Posted: | April 4, 2017 Key Record Dates |
| Results First Posted: | January 9, 2020 |
| Last Update Posted: | January 9, 2020 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
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Heart Failure Cardiac Pacing Cardiac Resynchronization Therapy Left Ventricular Lead |
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Heart Failure Heart Diseases Cardiovascular Diseases |