Quadripolar Pacing Post Approval Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT01555619
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this post-approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy (CRT).

Detailed Description

Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so. Patients enrolled in the study will be followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years). After patients complete 60 months of follow-up, their participation in the study will be terminated.

Study Timeline

• Study Start: 2012-02-15
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1971

Inclusion Criteria

1. Approved indication per current American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s).
2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing implantable cardioverter-defibrillator or pacemaker implant with no prior LV lead placement.
3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
2. Have a life expectancy of less than 5 years due to any condition
3. Be less than 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication free survival rate related to the CRT-D system	5 years	Complication free survival rate through 5 years for complications related to the CRT-D system
Complication free survival rate related to the LV lead	5 years	Complication free survival rate at 5 years for complications related to the LV lead
Mean programmed LV lead pacing capture threshold	5 years	Mean programmed LV lead pacing capture threshold at 5 years

Trial Locations

Locations (71)

Cardiology, P.C.; 🇺🇸 Birmingham, Alabama, United States

Heart Center Research, LLC/Research Center; 🇺🇸 Huntsville, Alabama, United States

Southeastern Cardiology Consultants PC; 🇺🇸 Montgomery, Alabama, United States

Arizona Arrhythmia Research Center; 🇺🇸 Phoenix, Arizona, United States

Washington Regional Medical Center; 🇺🇸 Fayetteville, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Comprehensive Cardiovascular; 🇺🇸 Bakersfield, California, United States

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

USC Unversity Hospital; 🇺🇸 Los Angeles, California, United States

Fogarty Institute; 🇺🇸 Mountain View, California, United States

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