Clinical trial NCT03099655: Attain Stability™ Quad Clinical Study
Official title: Attain Stability™ Quad Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Cardiac Pacing
Cardiac Resynchronization Therapy
Left Ventricular Lead
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lead Complication-free Rate at 6 Months
timeFrame: Implant to 6 months post-implant
measure: 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)
timeFrame: 6 months post-implant
measure: 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)
timeFrame: 6 months post-implant
Secondary outcomes:
measure: Implant Success
timeFrame: During procedure
measure: Implant Duration
timeFrame: During procedure
measure: LV Pacing Capture Threshold (PCT) at 6 Months
timeFrame: Implant to 6 months post-implant
measure: LV Impedance at 6 Months
timeFrame: Implant to 6 months
measure: Post Implant Lead Failure Rate
timeFrame: Implant to 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group, LLC
state: Arizona
city: East Palo Alto
country: United States
facility: Sequoia Hospital
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Heart Specialists Pavilion Office
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative (Springfield IL)
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart Center (West Des Moines IA)
state: Iowa
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation Inc
state: Maryland
city: Marquette
country: United States
facility: DLP Marquette Physicians Practices Inc
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: HealthPartners Institute (Saint Louis Park MN)
state: Minnesota
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center (DUMC)
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Memphis
country: United States
facility: Sutherland Cardiology Clinic
state: Tennessee
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants L
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute (Plano TX)
state: Texas
city: Houston
country: United States
facility: CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Spokane
country: United States
facility: Kootenai Heart Clinics Northwest
state: Washington
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
city: Karlsruhe
country: Germany
facility: Klinik für Herzchirurgie Karlsruhe
city: Lüdenscheid
country: Germany
facility: Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara - National Heart Institute
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Zwolle
city: Bergen
country: Norway
facility: Helse Bergen HF - Haukeland Universitetssjukehus
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
Study officials:
affiliation: Vanderbilt University Medical Center
name: George Crossley III, MD
role: PRINCIPAL_INVESTIGATOR
References: