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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Promote Q CRT-D and Quartet LV lead

Primary outcomes

Freedom From Left Ventricular Lead-Related Complications Through 3 Months

Time frame: 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

Time frame: 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.

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study

Acronym: Promote Q

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2012
First posted: Oct 7, 2009
Registry last updated: Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed