Attain Stability™ Quad Clinical Study

Medtronic

Status

Completed

Conditions

Heart Failure

Treatments

Device: Attain Stability Quad Left Ventricular Pacing Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT03099655

Attain Stability Quad

Details and patient eligibility

About

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).

Full 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.

Enrollment

471 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead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