N/A
Completed N=440
Attain Stability™ Quad Clinical Study
Source: ClinicalTrials.gov NCT03099655 ↗Enrolled (actual)
440
Serious AEs
33.4%
Results posted
Jan 2020
Primary outcomePrimary: Lead Complication-free Rate at 6 Months — 97.59 Survival Probability (% of subjects)
Summary
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lead Complication-free Rate at 6 Months |
97.59 | — |
| PRIMARY 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) |
96.29 | — |
| PRIMARY 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) |
94.16 | — |
| SECONDARY Implant Success |
96.8 | — |
| SECONDARY Implant Duration |
93; 19; 7 | — |
| SECONDARY LV Pacing Capture Threshold (PCT) at 6 Months |
1.07 | — |
| SECONDARY LV Impedance at 6 Months |
557.7 | — |
| SECONDARY Post Implant Lead Failure Rate |
0.23; 0.23; 0.70; 0.70; 0.23; 0.23 | — |
Eligibility 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- Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead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
Data sourced from ClinicalTrials.gov (NCT03099655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.