Attain Performa(TM) Quadripolar Lead Study

Heart Failure Clinical Trial

Official title:

Attain Performa(TM) Quadripolar Lead Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751022
• Other study ID #: Attain Performa(TM)
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: October 1, 2015
• Start date: December 2012
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1206
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Chile,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Malaysia,  Netherlands,  Norway,  Romania,  Saudi Arabia,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead complication-free rate at 6 months		Implant to 6 months post-implant	No
Primary	LV pacing capture thresholds per Attain Performa Lead Model		6 months post-implant	No
Secondary	Proportion of subjects with presence of PNS calculated for every LV lead pacing polarities that valid pacing capture thresholds can be obtained.		6 months post-implant	No
Secondary	Proportion of subjects with successful implant per Attain Performa Lead Model		Implant up to 1-month post implant	No
Secondary	Rate of overall acceptable lead handling per Attain Performa Lead Model	Implanter questionnaire to assess lead handling experience.	Implant up to 1-month post implant	No
Secondary	Pacing capture thresholds at the final programmed pacing polarity		12 months post-implant	No
Secondary	Total implant time per Attain Performa Lead Model		Implant up to 1-month post implant	No
Secondary	Pacing impedance at the final programmed pacing polarity		12 month post-implant	No
Secondary	Failure rate for individual Attain Performa Lead related events		6 month post-Implant	No
Secondary	Fluoroscopy time per Attain Performa Lead Model		Implant up to 1-month post implant	No
Secondary	Cannulation time per Attain Performa Lead Model		Implant up to 1-month post implant	No
Secondary	LV Lead placement time per Attain Performa Lead Model		Implant up to 1-month post implant	No