Antibacterial Envelope for Prevention of Infection Following CRM Device Replacement with an ICD. Citadel. PI. Mark Preminger, MD
Eligibility: Any patient receiving the Aigis patch on a replacement device Description: Patient follow-up visits to assess for infection.
Principal Investigator: Suneet Mittal, MD Sponsor: Biotronik Purpose: The purpose of this clinical research study is to determine if early awareness of an abnormal heart rhythm with Home Monitoring (HM) in combination with anticoagulation (blood thinning) medication is able to reduce the risk of stroke, systemic blood clots, and major bleeding episodes in patients implanted with dual-chamber ICDs or CRT Ds. Eligibility: Class III heart failure. No history of Atrial Fib Candidates for implantation of or already implanted with a BIOTRONIK Lumax HF-T or DR-T device Description: This study will help doctors to determine whether HM detection of abnormal atrial heart rhythms and early use of blood thinning medication in patients implanted with ICDs or CRT-Ds can reduce the chance of stroke and systemic blood clots.
Principal Investigator: Suneet Mittal, MD Sponsor: Forest Research Institute, Inc. Purpose: The main purpose of this study is to see if a drug called azimilide, an investigational (experimental) new drug not yet approved by a regulatory agency (like the US Food and Drug Administration (FDA)) can help people with an ICD have fewer cardiovascular (heart-related) emergency room visits and hospitalizations than participants not receiving azimilide. Eligibility: Left ventricular ejection fraction < 40% as determined by echocardiography, nuclear scan, left ventriculography, or cardiac magnetic resonance imaging within 120 days, implanted ICD. Description: The subjects will be assigned randomly to take either azimilide or placebo. The study will compare azimilide with a placebo in regards to frequency of the cardiac events.
Principal Investigator: Dan Musat, MD Sponsor: NIH and University of Rochester Purpose: To see how effective a drug called ranolazine is in reducing the risk of fast cardiac arrhythmias and death in people with ICDs. This drug will be used with standard medications that your doctor will use to treat your heart. Eligibility: Subjects with ischemic or nonischemic cardiomyopathy qualified for ICD (or CRT-D) therapy after documented ventricular tachycardia or cardiac arrest. Description: Ranolazine has been approved by the United States Food and Drug Administration for the treatment for patients with heart disease. It has not been approved for the prevention and treatment for irregular and dangerous heart beat rhythms from the lower heart chambers.
Principal Investigators: Suneet Mittal, MD & John E. Strobeck, MD Sponsor: Medtronic, Inc. Purpose: To evaluate a method of identifying people at greater risk of going to the hospital for their heart failure (IDENTIFY-HF Risk Status Algorithm) Eligibility: Subjects who already have a Reveal® insertable cardiac monitor or who are recommended to receive an insertable cardiac monitor for management of heart condition. Description: This study is to learn if IDENTIFY-HF Risk Status Algorithm that uses information from the Reveal® insertable cardiac monitor calculates a heart failure risk status is able to predict the risk of a patient for going to the hospital for their heart condition.
Principal Investigator: Jonathan Steinberg, MD Sponsor: The Chinese University of Hong Kong Purpose: The purpose of this study is to complete a large scale database to attempt to establish a comprehensive clinical score that will predict a favorable CRT response. Eligibility: Patients with HF due to systolic dysfunction aged 18 or above and willing to sign consent form. Description: Patients who undergo CRT will undergo typical clinical testing and the data will be collected prospectively to be merged with data from several international centers. The clinical response to CRT will be monitored.
Principal Investigator: Suneet Mittal, MD Sponsor: Biosense Purpose: To determine whether catheter ablation procedure for AF in patients with poor heart function (heart failure) using RF energy would restore normal heart function Eligibility: Class I-III heart failure Patients are required to have specific medical conditions and must meet specific standards to qualify for treatment. Description: This is an observational study to collect information on patients with atrial fibrillation and heart failure undergoing catheter ablation procedure. This study will examine whether restoration and maintenance of sinus rhythm by catheter ablation in atrial fibrillation and heart failure improves heart failure status.
Principal Investigator: Suneet Mittal, MD Sponsor: Biosense Purpose: To determine how often a fast and irregular heart rhythm called atrial fibrillation occurs after the ablation procedure that the patient has been previously undergone to manage a related arrhythmia call atrial flutter. Eligibility: No prior documented history of AF and no existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device) Description: After atrial flutter ablation the subjects will undergo implantation of an ILR. Subjects will be followed using the data from ILR to evaluate if they develop atrial fibrillation.
Principal Investigator: Jonathan S. Steinberg, MD Sponsor: Biosense Purpose: To compare the two standard AF treatments; catheter ablation or anti-arrythmic drug therapy using continuous monitoring among patient with recently diagnosed paroxysmal AF. Eligibility: Subjects with atrial fibrillation eligible for catheter ablation. Description: The two treatment modalities, (1) antiarrhythmic drugs and (2) catheter ablation, are both standard treatment modalities for AF. ILR is an FDA approved for monitoring the heart rate and its irregularities. It is common practice to have failed at least one antiarrhythmic drug prior to catheter ablation. This study aims to compare early treatment with catheter ablation versus antiarrhythmic drug therapy.
For more information on any of these clinical trials, please call or email Kathleen Sayles. 201-447-8453 or ksayles@valleyhealth.com.