Home » Clinical Trials In Cardiac Rhythm Management » MADIT-CRT Journal Disclosure
CAUTION — Investigational device. Limited by Federal law to investigational use. The safety and effectiveness of Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) in the MADIT-CRT patient population have not been established and are not part of the FDA-approved device indications.
Boston Scientific is the sole sponsor of the MADIT-CRT clinical trial and manufactures implantable cardioverter defibrillators (ICDs) as well as CRT-Ds.
This study was supported by a research grant from Boston Scientific Corporation, St. Paul, MN, to the University of Rochester, with funds distributed to the coordination and data center, enrolling centers, core laboratories, committees, and boards under subcontracts from the University of Rochester. There were no agreements concerning confidentiality between the sponsor and the authors or the institutions named in the credit lines. Dr. Moss reports receiving funding from Boston Scientific, including grant support and lecture fees; Dr. Cannom funding from Boston Scientific, including lecture and consulting fees; Dr. Daubert receiving funding from Boston Scientific, including lecture fees and institutional fellowship support; Dr. Estes receiving funding from Boston Scientific, including lecture fees and institutional fellowship support; Dr. Higgins receiving funding from Boston Scientific, including lecture and consulting fees and reports being a part-time paid consultant to Boston Scientific from June 23, 2009 to August 3, 2009; Dr. Klein receiving funding from Boston Scientific, including grant support and lecture fees; Dr. Solomon receiving funding from Boston Scientific, including consulting fees from Boston Scientific; Dr. Pfeffer receiving funding from Boston Scientific, including consulting fees; Dr. Wilber receiving funding from Boston Scientific, including lecture fees, grant support, and institutional fellowship support; and Dr. Zareba receiving funding from Boston Scientific, including lecture fees. No other compensation or financial interests were reported.
BSC is not aware of any additional risks or safety concerns about this unapproved use outside of what is discussed in the journal article. Per the study protocol, adverse events were monitored by an independent data and safety monitoring board (DSMB). The DSMB did not inform BSC of any significant risks or safety concerns in this patient population during the course of the study.
Please refer to the bibliography contained within the MADIT-CRT publication for a comprehensive bibliography of other clinical studies about the use of ICDs and CRT-Ds.
The following statements are based on clinical information consistent with current device labeling and are not based on published MADIT-CRT Trial Results. For the current CRT-D labeling, go to www.bostonscientific.com/ifu.
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF ≤ 35%) and QRS duration≥ 120 ms.
There are no contraindications for this device.
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in patient injury or death. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator protection available during implant. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient's death. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents. Do not use atrial-tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. Do not use atrial only modes in patients with heart failure because such modes do not provide CRT. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. Do not use defibrillation patch leads with the CRT-D system, or injury to the patient may occur. Do not use this pulse generator with another CRM pulse generator. This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs. Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case, potentially leading to a component failure and device malfunction.
For information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization, storage and handling; implant and device programming; follow-up testing; explant and disposal; environmental and medical therapy hazards; hospital and medical environments; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
Potential adverse events from implantation of the CRT-D system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, and component failure. In rare cases severe complications or device failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only.
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