Personalized Therapy Study - Attain Stability Quad Post-Approval Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Rhône Durance, Avignon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Quadripolar LV Lead

Device

The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is an active fixation quadripolar LV lead based on the Attain Performa lead family models (4298, 4398, and 4598). The lead incorporates an active fixation helix similar to the OUS commercialized Attain Stability bipolar LV lead (Model 20066/4796) which is designed to allow an implanter more options in lead location.

Other names: Medtronic CRT-P, Medtronic CRT-D

Primary outcomes

Percentage of patients without a lead- related event at 5 years post-implant

Time frame: 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 outcomes

Number of lead-related adverse device effects

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Acronym: ASQ

Important dates

Study start: 2017
Primary completion: 2027
Study completion: 2028
First posted: Jul 18, 2019
Registry last updated: Feb 4, 2026

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.

Active, Not Recruiting