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Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study (Promote Q)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring CRT, Heart Failure, LV Leads

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
  • Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
  • Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Have had a recent CVA or TIA within three months of enrollment
  • Have a contraindication for an emergency thoracotomy
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
  • Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
  • Have undergone a cardiac transplantation within 40 days of enrollment
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
  • Are currently participating in a clinical investigation that includes an active treatment arm
  • Are pregnant or planning to become pregnant during the duration of the study
  • Have a life expectancy of less than 6 months due to any condition
  • Are less than 18 years of age
  • Are unable to comply with the follow up schedule

Sites / Locations

  • University Hospital of Alabama at Birmingham
  • Baptist Health Medical Center
  • Arkansas Heart Hospital
  • Glendale Memorial Medical Center
  • University of Southern California
  • ACS Research Group
  • Regional Cardiology Associates
  • Scripps Green Hospital
  • Orlando Heart Center
  • The Heart and Vascular Institute of Florida - S. Pinellas
  • Piedmont Hospital
  • Midwest Heart Foundation
  • Central Baptist Hospital
  • Lahey Clinical Medical Center
  • Thoracic Cardiovascular Healthcare Foundation
  • Deborah Heart and Lung Center
  • Morristown Memorial Hospital
  • Mount Sinai Hospital
  • The Cleveland Clinic Foundation
  • EMH Regional Medical Center
  • Lancaster Heart Foundation
  • Methodist University Hospital
  • St. Thomas Hospital
  • Arrhythmia Center for Southern Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT-D and LV lead

Arm Description

Outcomes

Primary Outcome Measures

Freedom From Left Ventricular Lead-Related Complications Through 3 Months
The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Freedom From System-related Complications Through 3 Months
The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).

Secondary Outcome Measures

Full Information

First Posted
October 6, 2009
Last Updated
February 7, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00990665
Brief Title
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
Acronym
Promote Q
Official Title
Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT, Heart Failure, LV Leads

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CRT-D and LV lead
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Intervention Description
Promote Q CRT-D and Quartet LV lead
Primary Outcome Measure Information:
Title
Freedom From Left Ventricular Lead-Related Complications Through 3 Months
Description
The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Time Frame
3 months
Title
Freedom From System-related Complications Through 3 Months
Description
The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
Time Frame
3 Months
Title
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
Description
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s) Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement. Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Have had a recent CVA or TIA within three months of enrollment Have a contraindication for an emergency thoracotomy Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months Have undergone a cardiac transplantation within 40 days of enrollment Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment Are currently participating in a clinical investigation that includes an active treatment arm Are pregnant or planning to become pregnant during the duration of the study Have a life expectancy of less than 6 months due to any condition Are less than 18 years of age Are unable to comply with the follow up schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gery Tomassoni, MD
Organizational Affiliation
Central Baptist Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Baptist Health Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Glendale Memorial Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
ACS Research Group
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Scripps Green Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Orlando Heart Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Heart and Vascular Institute of Florida - S. Pinellas
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Lahey Clinical Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Thoracic Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
EMH Regional Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Lancaster Heart Foundation
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Arrhythmia Center for Southern Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23339555
Citation
Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.
Results Reference
result

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Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

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