Attain Performa(TM) Quadripolar Lead Study

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01751022

Attain Performa(TM)

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.

Enrollment: 1,202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines)
• Patient (or legally authorized representative) has signed and dated the study-specific Consent Form
• Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
• Patient is expected to remain available for follow-up visits
• Patient understands the study and agrees to comply with study protocol

Exclusion criteria

• Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt

• Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)

• Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study)

• Patient is contraindicated for < 1 mg dexamethasone acetate

• Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager)

• Patient has a life expectancy less than 180 days

• Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)

  • In US, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included

• Patient is unable to tolerate an urgent thoracotomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,202 participants in 1 patient group

Attain Performa LV Lead (Models 4298, 4398, 4598)

Experimental group

Description:

N/A: single arm study, separate analysis for each lead model (total of 3).

Treatment:

Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)