Attain Stability™ Quad Clinical Study

NCT03099655 | Completed Results FDA Device

• 1 other identifier: Attain Stability Quad
• Study Type: interventional
• Target: 471
• Locations: 10 countries
• Sites: 50

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).

Conditions

Heart Failure

Keywords

Heart Failure; Cardiac Pacing; Cardiac Resynchronization Therapy; Left Ventricular Lead

Outcome Measures

Primary Outcomes (3)

• Lead Complication-free Rate at 6 Months

  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.

  Implant to 6 months post-implant

• 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)

  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%.

  6 months post-implant

• 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)

  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%.

  6 months post-implant

Secondary Outcomes (5)

• Implant Success

  During procedure

• Implant Duration

  During procedure

• LV Pacing Capture Threshold (PCT) at 6 Months

  Implant to 6 months post-implant

• LV Impedance at 6 Months

  Implant to 6 months

• Post Implant Lead Failure Rate

  Implant to 6 months

Study Arms (1)

Attain Stability Quad Lead

EXPERIMENTAL

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

Device: Attain Stability Quad Left Ventricular Pacing Lead

Interventions

Attain Stability Quad Left Ventricular Pacing Lead DEVICE

cardiac stimulation

Also known as: 4798 Lead

Attain Stability Quad Lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 is unable to tolerate an urgent thoracotomy

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (50)

Phoenix Cardiovascular Research Group, LLC

Phoenix, Arizona, 85006, United States

Location

Sequoia Hospital

East Palo Alto, California, 94062, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Baptist Heart Specialists Pavilion Office

Jacksonville, Florida, 32216, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Prairie Education & Research Cooperative (Springfield IL)

Springfield, Illinois, 62701, United States

Location

Iowa Heart Center (West Des Moines IA)

West Des Moines, Iowa, 50266, United States

Location

Delmarva Heart Research Foundation Inc

Salisbury, Maryland, 21804, United States

Location

DLP Marquette Physicians Practices Inc

Marquette, Michigan, 49855, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

HealthPartners Institute (Saint Louis Park MN)

Saint Louis Park, Minnesota, 55426, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Sutherland Cardiology Clinic

Memphis, Tennessee, 38103, United States

Location

Centennial Heart Cardiovascular Consultants L

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Baylor Research Institute (Plano TX)

Dallas, Texas, 75226, United States

Location

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

Houston, Texas, 77030, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Kootenai Heart Clinics Northwest

Spokane, Washington, 99204, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

University of Calgary

Calgary, T2N 4N1, Canada

Location

London Health Sciences Centre - University Campus

London, N6A 5A5, Canada

Location

Southlake Regional Health Centre

Newmarket, L3Y 8C3, Canada

Location

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

Québec, G1V 4G5, Canada

Location

Klinik für Herzchirurgie Karlsruhe

Karlsruhe, 76185, Germany

Location

Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

Lüdenscheid, 58515, Germany

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

Pisa, 56100, Italy

Location

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Isala Zwolle

Zwolle, 8011 JW, Netherlands

Location

Helse Bergen HF - Haukeland Universitetssjukehus

Bergen, 5021, Norway

Location

Hospital Universitario Ramón y Cajal

Madrid, 28050, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47006, Spain

Location

Karolinska Universitetssjukhuset

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Erika Pouliot
• Organization: Medtronic

erika.pouliot@medtronic.com

+17635261270

Study Officials

• George Crossley III, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 4, 2017
• Study Start: July 7, 2017
• Primary Completion: August 2, 2018
• Study Completion: May 31, 2019
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (35); HK (1); CA (4); IT (1); DE (2); ES (2); MY (1); NL (2); NO (1); SE (1)