Attain Stability™ Quad Clinical Study

NCT ID: NCT03099655

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 471 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-07
• Study Completion Date: 2019-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Attain Stability Quad Lead

Attain Stability Quad Lead (Model 4798) - Single arm study.

Group Type: EXPERIMENTAL

Attain Stability Quad Left Ventricular Pacing Lead

Intervention Type: DEVICE

cardiac stimulation

Interventions

Attain Stability Quad Left Ventricular Pacing Lead

cardiac stimulation

Intervention Type: DEVICE

Other Intervention Names

4798 Lead

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 is unable to tolerate an urgent thoracotomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Crossley III, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Sutherland Cardiology Clinic

Memphis, Tennessee, United States

Centennial Heart Cardiovascular Consultants L

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Research Institute (Plano TX)

Dallas, Texas, United States

CHI Saint Luke's Health - Baylor Saint Luke's Medical Center

Houston, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Kootenai Heart Clinics Northwest

Spokane, Washington, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

University of Calgary

Calgary, , Canada

London Health Sciences Centre - University Campus

London, , Canada

Southlake Regional Health Centre

Newmarket, , Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, , Canada

Klinik für Herzchirurgie Karlsruhe

Karlsruhe, , Germany

Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

Lüdenscheid, , Germany

Prince of Wales Hospital

Hong Kong, , Hong Kong

Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, , Malaysia

Catharina Ziekenhuis

Eindhoven, , Netherlands

Isala Zwolle

Zwolle, , Netherlands

Helse Bergen HF - Haukeland Universitetssjukehus

Bergen, , Norway

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Countries

United States; Canada; Germany; Hong Kong; Italy; Malaysia; Netherlands; Norway; Spain; Sweden

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Attain Stability Quad

Identifier Type: -

Identifier Source: org_study_id