N/A
N=466
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT01528150 ↗Enrolled (actual)
466
Serious AEs
37.3%
Results posted
Aug 2016
Primary outcome: Primary: Freedom From RA and RV Lead-related Complications — 97.19; 99.14 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From RA and RV Lead-related Complications |
97.19; 99.14 | — |
Summary
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.
Eligibility Criteria
Inclusion Criteria
- Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
- Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
- Is ≥ 18 years of age.
- Able to provide written informed consent prior to any investigational related procedure.
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
- Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
- Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.).
- Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
- Have a lead extender, plug or adaptor.
- Have a prosthetic tricuspid heart valve.
- Are currently participating in another investigational device or drug investigation.
- Are allergic to Dexamethasone sodium phosphate (DSP).
- Are pregnant or planning to become pregnant during the duration of the study.
- Have a life expectancy of less than 12 months from Screening due to any life-threatening condition
Data sourced from ClinicalTrials.gov (NCT01528150). 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.