Attain Stability™ Quad Clinical Study

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Attain Stability Quad Left Ventricular Pacing Lead

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.

• Study Type: Interventional
• Enrollment (Actual): 471
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada, T2N 4N1
    • University of Calgary
  • London, Canada, N6A 5A5
    • London Health Sciences Centre - University Campus
  • Newmarket, Canada, L3Y 8C3
    • Southlake Regional Health Centre
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
• Germany
  • Karlsruhe, Germany, 76185
    • Klinik für Herzchirurgie Karlsruhe
  • Lüdenscheid, Germany, 58515
    • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Italy
  • Pisa, Italy, 56100
    • Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara - National Heart Institute
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Zwolle, Netherlands, 8011 JW
    • Isala Zwolle
• Norway
  • Bergen, Norway, 5021
    • Helse Bergen HF - Haukeland Universitetssjukehus
• Spain
  • Madrid, Spain, 28050
    • Hospital Universitario Ramón y Cajal
  • Valladolid, Spain, 47006
    • Hospital Clínico Universitario de Valladolid
• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska Universitetssjukhuset
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Cardiovascular Research Group, LLC
  • California
    • East Palo Alto, California, United States, 94062
      • Sequoia Hospital
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Baptist Heart Specialists Pavilion Office
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Education & Research Cooperative (Springfield IL)
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center (West Des Moines IA)
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Delmarva Heart Research Foundation Inc
  • Michigan
    • Marquette, Michigan, United States, 49855
      • DLP Marquette Physicians Practices Inc
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center
    • Saint Louis Park, Minnesota, United States, 55426
      • HealthPartners Institute (Saint Louis Park MN)
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Memorial Hospital
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
    • Voorhees, New Jersey, United States, 08043
      • Lourdes Cardiology Services
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center (DUMC)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital Research Foundation
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Sutherland Cardiology Clinic
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart Cardiovascular Consultants L
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Dallas, Texas, United States, 75226
      • Baylor Research Institute (Plano TX)
    • Houston, Texas, United States, 77030
      • CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Spokane, Washington, United States, 99204
      • Kootenai Heart Clinics Northwest
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attain Stability Quad Lead; Attain Stability Quad Lead (Model 4798) - Single arm study.	Device: Attain Stability Quad Left Ventricular Pacing Lead; cardiac stimulation; Other Names: 4798 Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Success	Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure	During procedure
Implant Duration	Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure.	During procedure
LV Pacing Capture Threshold (PCT) at 6 Months	Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit.	Implant to 6 months post-implant
LV Impedance at 6 Months	Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject	Implant to 6 months
Post Implant Lead Failure Rate	Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure	Implant to 6 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: George Crossley III, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronization Therapy; Cardiac Pacing; Left Ventricular Lead
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Attain Stability Quad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes