Attain Stability™ Quad Clinical Study
- Conditions
- Heart Failure
- Interventions
- Device: Attain Stability Quad Left Ventricular Pacing Lead
- Registration Number
- NCT03099655
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
- 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
- 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- Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Attain Stability Quad Lead Attain Stability Quad Left Ventricular Pacing Lead Attain Stability Quad Lead (Model 4798) - Single arm study.
- Primary Outcome Measures
Name Time Method 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) 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) 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%.Lead Complication-free Rate at 6 Months 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.
- Secondary Outcome Measures
Name Time Method Implant Success During procedure Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
Implant Duration 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.
Post Implant Lead Failure Rate 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
LV Impedance at 6 Months 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
LV Pacing Capture Threshold (PCT) at 6 Months 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.
Trial Locations
- Locations (50)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor Research Institute (Plano TX)
🇺🇸Dallas, Texas, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
🇺🇸Houston, Texas, United States
Helse Bergen HF - Haukeland Universitetssjukehus
🇳🇴Bergen, Norway
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Sequoia Hospital
🇺🇸East Palo Alto, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Iowa Heart Center (West Des Moines IA)
🇺🇸West Des Moines, Iowa, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Klinik für Herzchirurgie Karlsruhe
🇩🇪Karlsruhe, Germany
University of Calgary
🇨🇦Calgary, Canada
Isala Zwolle
🇳🇱Zwolle, Netherlands
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Phoenix Cardiovascular Research Group, LLC
🇺🇸Phoenix, Arizona, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Centennial Heart Cardiovascular Consultants L
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
HealthPartners Institute (Saint Louis Park MN)
🇺🇸Saint Louis Park, Minnesota, United States
Duke University Medical Center (DUMC)
🇺🇸Durham, North Carolina, United States
Baptist Heart Specialists Pavilion Office
🇺🇸Jacksonville, Florida, United States
Prairie Education & Research Cooperative (Springfield IL)
🇺🇸Springfield, Illinois, United States
Delmarva Heart Research Foundation Inc
🇺🇸Salisbury, Maryland, United States
DLP Marquette Physicians Practices Inc
🇺🇸Marquette, Michigan, United States
Sutherland Cardiology Clinic
🇺🇸Memphis, Tennessee, United States
Kootenai Heart Clinics Northwest
🇺🇸Spokane, Washington, United States
London Health Sciences Centre - University Campus
🇨🇦London, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Quebec, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Canada
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
🇩🇪Lüdenscheid, Germany
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
🇮🇹Pisa, Italy
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong