Attain Stability™ Quad Clinical Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03099655
• Date of registration: 14/03/2017
• Prospective Registration: Yes
• Primary sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Public title: Attain Stability™ Quad Clinical Study
• Scientific title: Attain Stability™ Quad Clinical Study
• Date of first enrolment: July 7, 2017
• Target sample size: 471
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03099655
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, Germany, Hong Kong, Italy, Malaysia, Netherlands, Norway, Spain, Sweden, United States

Contacts

• Name: George Crossley III, MD
• Affiliation: Vanderbilt University Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient meets CRT implant criteria as determined by local regulatory and/or hospital
policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA
guidelines)

- Patient (or legally authorized representative) has signed and dated the study-specific
Informed 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

Exclusion Criteria:

- Patient has had a previous unsuccessful LV lead implant attempt

- Patient has a previous CRT system or LV lead implanted (for example, transvenous or
epicardial)

- Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or
safety alert) RA and/or RV lead

- Patient has known coronary venous vasculature that is inadequate for lead placement

- Patient has unstable angina pectoris or has had an acute myocardial infarction (MI)
within the past 30 days

- Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal
coronary angioplasty (PTCA) within the past 90 days

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

- Patient has had a heart transplant (patients waiting for heart transplants are allowed
in the study)

- Patient has known renal insufficiency that would prevent them from receiving an
occlusive venogram during the implant procedure

- Patient is contraindicated for <1mg dexamethasone acetate

- Patient is enrolled in any concurrent drug and/or device study that may confound the
results of this study

- Patient has a terminal illness and is not expected to survive more than six months

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

- Patient is unable to tolerate an urgent thoracotomy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: Attain Stability Quad Left Ventricular Pacing Lead

Primary Outcome(s)

Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT = 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS) [Time Frame: 6 months post-implant]

Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT =2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS) [Time Frame: 6 months post-implant]

Lead Complication-free Rate at 6 Months [Time Frame: Implant to 6 months post-implant]

Secondary Outcome(s)

Implant Duration [Time Frame: During procedure]

Post Implant Lead Failure Rate [Time Frame: Implant to 6 months]

Implant Success [Time Frame: During procedure]

LV Impedance at 6 Months [Time Frame: Implant to 6 months]

LV Pacing Capture Threshold (PCT) at 6 Months [Time Frame: Implant to 6 months post-implant]

Secondary ID(s)

Attain Stability Quad

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03099655