Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Active, not recruiting

• Conditions: Heart Failure

• Registration Number: NCT04024943
• Lead Sponsor: Medtronic

Brief Summary

The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

Detailed Description

The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.

Study Timeline

• Study Start: 2017-08-21
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2027-01
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1092

Inclusion Criteria

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has or is intended to receive or be treated with a Model 4798 lead and a Medtronic CRT device
• Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients without a lead- related event at 5 years post-implant	5 years	To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads.

Secondary Outcome Measures

Name	Time	Method
Number of lead-related adverse device effects	5 years	The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product: • To summarize all Attain Stability Quad lead-related ADEs
Number of explanted leads that have been returned	5 years	The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product: • To summarize analysis results from explanted and returned Attain Stability Quad leads

Trial Locations

Locations (115)

Alaska Heart; 🇺🇸 Anchorage, Alaska, United States

Southwest EP; 🇺🇸 Chandler, Arizona, United States

Cardiology Associates of Northeast Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

Saint Vincent Heart Clinic Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Chula Vista Cardiac Center; 🇺🇸 Chula Vista, California, United States

San Diego Arrhythmia Associates; 🇺🇸 San Diego, California, United States

COR Healthcare; 🇺🇸 Torrance, California, United States

Cardiovascular Consultants Medical Group (Van Nuys); 🇺🇸 Van Nuys, California, United States

Cardiology Associates Medical Group; 🇺🇸 Ventura, California, United States

Colorado Springs Cardiology; 🇺🇸 Colorado Springs, Colorado, United States

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