Device for prevention of clots for Atrial Fibrillation
The condition of Atrial Fibrillation can cause blood to stagnate and form clots in an area of the heart called the left atrial appendage. Everyone has a left atrial appendage and if a clot forms there, it increases the changes of causing a stroke or other related problems. Treatments currently available reduce risks of clots and may include a doctor's prescription for a blood thinning medication, coumadin. As an alternative, there is a WATCHMAN device that is a left atrial appendage filter. This implantable device is currently being studied to reduce the risks of clots and be an alternative to long-term use of coumadin. For Atrial Fibrillation patients eligible for blood thinning medications, this study device may be an alternative.
Principal Investigators: Dr. Tuzcu, Dr. Kapadia, Dr. Natale, Dr. Whitlow
Clinical Research Coordinator: Rose Bartow, R.N. (216) 445-7187
Protocols for the Treatment of Atrial Fibrillation
The basic goal in the treatment for atrial fibrillation is to restore normal sinus rhythm to the heart, and, if possible, prevent its recurrence. Sometimes, it is not possible to convert atrial fibrillation to a normal rhythm, and then the goal is to decrease its effect and symptoms for the patient. Various treatments presently exist for atrial fibrillation:
- Medications to convert or slow the rapid irregular heart beat
- Electric shock to restore the rhythm
- Implantable devices that detect and overdrive or shock the heart automatically to convert the rhythm
- Surgical procedures to interrupt the conduction pathways that sustain atrial fibrillation
- Combination of drugs, devices and procedures.
Implantable Devices
Currently under investigation is an automatic device, similar in size to a pack of cards, that is implanted in the upper chest with leads (wires) connecting the device to the heart. The device continuously monitors the heart beat through the leads, and has the ability to detect when the heart goes into atrial fibrillation. The device is programmable to treat the arrhythmia in a variety of ways, including automatic therapy, physician initiated therapy, or patient activated therapy. This device is also being tested in combination with approved drug therapy to see if the combination therapy is more effective, or better tolerated, than device or drug alone.
Physician: Mina Chung, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Ablation/Pacemaker Therapy for Atrial Fibrillation
Patients who have failed drug therapy to control their rhythm and continue to experience symptoms from the rapid or slow heart-beat that occurs with atrial fibrillation can be treated with a pacemaker. One method is to use a pacemaker in combination with drug therapy. The medication can slow the fast conduction of electrical impulses from the atria to the ventricles, but often can cause it to be too slow; the pacemaker is then used to protect the heart from the slow heart rate.
In some patients, medication doesn’t work, or is intolerable to the patient, and a procedure can be done to totally or partially block the impulses from the atria to the ventricles. A pacemaker is used in this instance to maintain a suitable heart rate. The procedure to create the conduction block from the atria to the ventricles is called an ablation. During an ablation procedure of this type, the tissue junction that normally conducts the electrical impulse from the atria to the ventricle is destroyed. This occurs when energy is directed at the tissue junction (AV Node) via a catheter that is threaded into the heart and placed on the target tissue, creating a lesion that destroys the tissue and interrupts any flow of electrical activity. These procedures described are standard treatments available. Some Research Protocols currently available use new investigational tools, catheters, or energy sources to perform the ablation procedures. Click here to learn more about ablation.
Ablation Studies for the treatment of Atrial Fibrillation, Atrial Flutter or other Supraventricular Arrythmias
Ablation studies evaluating new catheters and generators for radiofrequency energy to create the lesions that destroys the targeted conduction pathway.
Physicians: Patrick Tchou, MD, Mark Niebauer, MD, Andrea Natale, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Ablation study evaluating new catheters and system console using cryogenic energy to create the lesions that destroys the targeted conduction pathway.
Physician: Patrick Tchou, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Ablation studies evaluating a new balloon catheter and generator for ultrasonic energy to create the lesions that destroys tissue in the pulmonary veins thought to initiate or sustain atrial fibrillation (On Hold) .
Physician: Andrea Natale, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Cause Determination Studies
Other studies underway at Cleveland Clinic Foundation Heart Center for patients in atrial fibrillation are not geared to treatment of the arrhythmia, but to the determination of the cause. These studies are examining blood samples of patients with atrial fibrillation at various times in their treatment cycles to try to elicit common characteristics of blood components and genetic make-up.
Physicians: Mina Chung, MD; Mark Niebauer, MD; Qing Wang, David Van Wagoner, PhD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Alternate Site Pacing Studies for Patients with CHF and Atrial Fibrillation
Pacemaker lead placement for patients receiving a single lead ventricular pacemaker is generally located in the apex (bottom) of the right ventricle. A study is currently underway to compare lead placement positions that pace from the bottom of the left ventricle (apex) or pace from the top of the left ventricle. Normal electrical flow in the heart is from top to bottom. When the pacemaker lead is in the bottom of the heart, the electrical activation can be retrograde, causing a backward, or less than optimum contraction of the heart muscle. The theory is that by placing the lead higher in the ventricle it will more closely mimic normal electrical activation and contraction of the ventricle.
Physician: Bruce L. Wilkoff, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Device Treatments for Patients with Congestive Heart Failure (CHF)
CHF results from a weakened cardiac muscle. The causes can be numerous, but the end result is a poorly contracting ventricle that cannot pump blood through the heart, and results in a backup of fluid into the lungs. This causes the patient to experience shortness of breath, and loss of energy. The damaged ventricular muscle stretches to try to compensate for its weak contraction, until it ends up "over-stretched." As the heart contracts, the weakened portion of the ventricle cannot keep up the normal heart muscle, and ends up in a floppy, unsynchronized contraction. The electrical conduction in this part of the weakened heart is also stretched, effecting the timing of the contraction.
Devices used for CHF
By pacing both of the ventricles with an implantable "pacemaker", the timing can be re-adjusted to help improve the timing of the contraction, with the goal to "re-synchronize" the contraction until optimal cardiac output is achieved. Bi-Ventricular pacing for the treatment of heart failure is now being evaluated in some of the Research protocols available at the Cleveland Clinic Foundation, with the aim to determine if Quality of Life and functioning of heart failure patients is improved.
Another threat posed to patients with CHF is the development at times of serious and often life-threatening arrhythmias. Studies are underway that use the implantation of a prophylactic implantable cardioverter defibrillator (ICD), or prophylactic anti-arrhythmic medication to determine if life-span as well as Quality of Life issues will improve.
Physician: Bruce L. Wilkoff, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Devices used to treat Ventricular Tachycardia and Ventricular Fibrillation
Cardioverter Defibrillator Outpatient Study
This study is evaluating an external defibrillator worn as a vest garment that continuously monitors patients for syncopal VT/VF, and once detected, the device provides an electrical shock to terminate the arrhythmia and restore normal heart rhythm. Patient enrollment is limited to those who are on the heart transplant list, or who have an equivalent heart condition status and are not candidates for implantable devices for various reasons. Strict inclusion and exclusion criteria are followed for enrollment.
Physician: Patrick Tchou, MD, James Young, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
VT Ablation
The primary purpose of this study is to demonstrate that a new investigational ablation catheter can be used to safely and effectively ablate recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction.
Physician: Andrea Natale, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Implantable Cardioverter Defibrillator (ICD) Study
The Cleveland Clinic is enrolling in a new study evaluating the safety and efficacy of an investigational ICD for patients meeting standard implant criteria. The new device not only detects and treats (shocks) serious ventricular arrhythmias, but also incorporate a dual chamber pacemaker that can respond to a patient’s increased activity by pacing the heart at a faster rate.
Physicians: Bruce L. Wilkoff, MD, Mark Niebauer, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Prophylactic ICD Study to Prevent Sudden Cardiac Death in "High Risk" Patients
A study is currently underway that evaluates the effectiveness of standard care, standard care plus prophylactic antiarrhythmic drug, and/or standard care plus ICD in the prevention of sudden cardiac death in patients with left ventricular dysfunction (EF< 35%).
Physicians: Patrick Tchou, MD, Andrea Natale, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Dual Chamber And VVI Implantable Defibrillator Trial
The goal of this trial is to evaluate the theory that DDDR (rate response) pacing with maximal concomitant drug therapy will improve prognosis, improve the quality of life, and reduce the cost of treating patients with ICDs, compared with VVI (single chamber) back-up only pacing with maximal concomitant drug therapy.
Physician: Bruce L. Wilkoff, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Ventricular Arrhythmia Triggers
A study starting soon will examine what activities and exposures contribute to the incidence of Sudden Cardiac Death (SCD) due to primary arrhythmias. primary arrhythmias. This is a prospective study of patients with ICDs evaluating rate of events, and utilizes the ICD’s monitoring and storage capabilities to identify sympathetic activation during arrhythmic events. By collecting this information leading to the ICD therapy, factors may be identified to increase or decrease the risk of ICD discharge/incidence of SCD.
Physician: Mina Chung, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Comparison of the Incidence of Hypotension with Two Formulations of Intravenous Antiarrhythmic Medications Used in the Treatment of Ventricular Arrhythmias
This study is comparing the incidence of hypotension that occurs between two formulations of an IV medication (a class III antiarrhythmic agent) indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardias.
Physician: Walid Saliba, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Devices used for unconventional therapies and diagnostics
Use of Implantable Pacemakers in the Treatment of Vasovagal Syncope
We are currently enrolling in a randomized controlled double-blind trial of pacemaker therapy for prevention of syncope in patients with highly symptomatic vasovagal syncope
Physician: Bruce L. Wilkoff, MD
Contact: (216) 444-2200, ask for EP Research pager number 26403
Revised 6/03
