Attain StabilityTM Quad Clinical Study

Attain StabilityTM Quad Clinical Study - Attain StabilityQuad

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45275

Enrollment

Registered

2017-07-31

Start date

2017-08-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

desynchronization heart failure

Interventions

All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).

Attain Stability Quad

LV lead

Model 4798

Quadripolar

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy. - Patient has signed and dated the study-specific Consent Form

Exclusion criteria

Exclusion criteria: - Patient has had a previous unsuccessful LV lead implant attempt. - Patient has an existing epicardial LV lead

Design outcomes

Primary

Measure	Time frame
Primary Safety Objective: Lead complication-free rate at 6 months Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months	—

Secondary

Measure	Time frame
The secondary objectives are descriptive in nature and are intended to provide additional information about the Attain Stability Quad Model 4798 LV lead.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)