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Attain Stability™ Quad Clinical Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Attain Stability Quad Left Ventricular Pacing Lead
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiac Pacing, Cardiac Resynchronization Therapy, Left Ventricular Lead

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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  • Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead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

Sites / Locations

  • Phoenix Cardiovascular Research Group, LLC
  • Sequoia Hospital
  • Torrance Memorial Medical Center
  • Hartford Hospital
  • Yale New Haven Hospital
  • Baptist Heart Specialists Pavilion Office
  • Emory University Hospital
  • Piedmont Heart Institute
  • Prairie Education & Research Cooperative (Springfield IL)
  • Iowa Heart Center (West Des Moines IA)
  • Delmarva Heart Research Foundation Inc
  • DLP Marquette Physicians Practices Inc
  • Minneapolis Heart Institute Foundation
  • CentraCare Heart & Vascular Center
  • HealthPartners Institute (Saint Louis Park MN)
  • Morristown Memorial Hospital
  • The Valley Hospital
  • Lourdes Cardiology Services
  • Asheville Cardiology Associates
  • Carolinas Medical Center
  • Duke University Medical Center (DUMC)
  • The Lindner Research Center
  • Cleveland Clinic
  • The Ohio State University Wexner Medical Center
  • Oklahoma Heart Hospital Research Foundation
  • Oklahoma Heart Institute
  • Sutherland Cardiology Clinic
  • Centennial Heart Cardiovascular Consultants L
  • Vanderbilt University Medical Center
  • Texas Cardiac Arrhythmia Research Foundation
  • Baylor Research Institute (Plano TX)
  • CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
  • Sentara Norfolk General Hospital
  • Kootenai Heart Clinics Northwest
  • Aurora Saint Luke's Medical Center
  • University of Calgary
  • London Health Sciences Centre - University Campus
  • Southlake Regional Health Centre
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
  • Klinik für Herzchirurgie Karlsruhe
  • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
  • Prince of Wales Hospital
  • Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
  • Institut Jantung Negara - National Heart Institute
  • Catharina Ziekenhuis
  • Isala Zwolle
  • Helse Bergen HF - Haukeland Universitetssjukehus
  • Hospital Universitario Ramón y Cajal
  • Hospital Clínico Universitario de Valladolid
  • Karolinska Universitetssjukhuset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Attain Stability Quad Lead

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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%.
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%.

Secondary Outcome Measures

Implant Success
Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant 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.
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.
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
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

Full Information

First Posted
March 14, 2017
Last Updated
December 19, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03099655
Brief Title
Attain Stability™ Quad Clinical Study
Official Title
Attain Stability™ Quad Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Cardiac Pacing, Cardiac Resynchronization Therapy, Left Ventricular Lead

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attain Stability Quad Lead
Arm Type
Experimental
Arm Description
Attain Stability Quad Lead (Model 4798) - Single arm study.
Intervention Type
Device
Intervention Name(s)
Attain Stability Quad Left Ventricular Pacing Lead
Other Intervention Name(s)
4798 Lead
Intervention Description
cardiac stimulation
Primary Outcome Measure Information:
Title
Lead Complication-free Rate at 6 Months
Description
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.
Time Frame
Implant to 6 months post-implant
Title
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)
Description
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%.
Time Frame
6 months post-implant
Title
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)
Description
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%.
Time Frame
6 months post-implant
Secondary Outcome Measure Information:
Title
Implant Success
Description
Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
Time Frame
During procedure
Title
Implant Duration
Description
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.
Time Frame
During procedure
Title
LV Pacing Capture Threshold (PCT) at 6 Months
Description
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.
Time Frame
Implant to 6 months post-implant
Title
LV Impedance at 6 Months
Description
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
Time Frame
Implant to 6 months
Title
Post Implant Lead Failure Rate
Description
Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure
Time Frame
Implant to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Crossley III, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Cardiovascular Research Group, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Sequoia Hospital
City
East Palo Alto
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Baptist Heart Specialists Pavilion Office
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Prairie Education & Research Cooperative (Springfield IL)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Iowa Heart Center (West Des Moines IA)
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Delmarva Heart Research Foundation Inc
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
DLP Marquette Physicians Practices Inc
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
CentraCare Heart & Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
HealthPartners Institute (Saint Louis Park MN)
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center (DUMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Heart Hospital Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Sutherland Cardiology Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants L
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Research Institute (Plano TX)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Kootenai Heart Clinics Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
University of Calgary
City
Calgary
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
London Health Sciences Centre - University Campus
City
London
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
ZIP/Postal Code
L3Y 8C3
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Klinik für Herzchirurgie Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76185
Country
Germany
Facility Name
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Institut Jantung Negara - National Heart Institute
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Isala Zwolle
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Helse Bergen HF - Haukeland Universitetssjukehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47006
Country
Spain
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Attain Stability™ Quad Clinical Study

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