Attain Stability™ Quad Clinical Study

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT03099655

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

471

Starts

2017-07-07

Expected to finish

2019-05-31

Last updated by the study team

2020-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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• Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead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

Where it is running

• Phoenix Cardiovascular Research Group, LLC — Phoenix, Arizona, United States
• Sequoia Hospital — East Palo Alto, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Baptist Heart Specialists Pavilion Office — Jacksonville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Prairie Education & Research Cooperative (Springfield IL) — Springfield, Illinois, United States
• Iowa Heart Center (West Des Moines IA) — West Des Moines, Iowa, United States
• Delmarva Heart Research Foundation Inc — Salisbury, Maryland, United States
• DLP Marquette Physicians Practices Inc — Marquette, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
• HealthPartners Institute (Saint Louis Park MN) — Saint Louis Park, Minnesota, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Asheville Cardiology Associates — Asheville, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center (DUMC) — Durham, North Carolina, United States
• The Lindner Research Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Oklahoma Heart Hospital Research Foundation — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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