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

NCT00990665 | Completed Results DMC

• 1 other identifier: 60024498/E
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 24

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.

Conditions

Heart Failure

Keywords

CRT; Heart Failure; LV Leads

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  3 Months

Study Arms (1)

CRT-D and LV lead

EXPERIMENTAL

Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)

Interventions

CRT-D and LV lead (Quartet™ lead and Promote Q® device system) DEVICE

Promote Q CRT-D and Quartet LV lead

CRT-D and LV lead

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (24)

University Hospital of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Glendale Memorial Medical Center

Glendale, California, 91204, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

ACS Research Group

Mountain View, California, 94040, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Scripps Green Hospital

San Diego, California, 92037, United States

Location

Orlando Heart Center

Orlando, Florida, 32806, United States

Location

The Heart and Vascular Institute of Florida - S. Pinellas

St. Petersburg, Florida, 33705, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Lahey Clinical Medical Center

Burlington, Massachusetts, 01805, United States

Location

Thoracic Cardiovascular Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

Lancaster Heart Foundation

Lancaster, Pennsylvania, 17602, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Arrhythmia Center for Southern Wisconsin

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• 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.

  PMID: 23339555 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clay Cohorn: Director, Clinical Study Management
• Organization: St. Jude Medical

ccohorn@sjm.com

972 309 8087

Study Officials

• Gery Tomassoni, MD

  Central Baptist Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2012
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2019-02

Locations

US (24)