Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Study Description
This study is for patients who meet the Class I or Class II implantation criteria for dual chamber pacing according to the ACC/AHA guidelines and have experienced at least one episode of symptomatic PAT/Atrial Fibrillation within the last three months. In addition, must have one documented episode within one year in order to participate.
Contact Information
Status:
Name, Phone, Email:
Tirah Sheppard
801-213-2278
tirah.sheppard@hsc.utah.edu
Principle Investigator:
Roger A. Freedman, M.D.
Please Note:
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Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.
Participant Eligibility
Inclusion Criteria:- Participants must be age 18 or older
- Patients that meet the Class I or II pacemaker implantation criteria for dual chamber pacing according to the guidelines described by ACC/AHA
- Patients who have had the following documented paroxysmal atrial tachy-arrhythmia experience:
a) One episode, either symptomatic or not symptomatic, in the year prior to enrollment (documented by a rhythm strip such as ECG or EGM)
b) Two symptomatic episodes in the three months prior to enrollment (documented in the patient chart). The episode documented by rhythm strip can be, but is not required to be one of the two symptomatic episodes.
c) Patients who are expected to remain on a stable regimen of drugs that have a primary antiarrhythmic effect (this includes patients who are not taking any such medications throughout the follow-up duration).
d) Patients who are willing and physically capable of using the Patient Assistant.
e)Patients who are geographically stable and willing to return to the hospital of clinic according to the follow up schedule. - Each patient, or legal representative must sign the combined informed consent and HIPAA authorization form as a condition for participating in this study.
- Patients who have permanent or persistent (not self terminating) atrial fibrillation.
- Patients who have atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance.
- Patients who are a current or immediate candidate for an implantable cardioverter defibrillator (ICD)
- Patients who have a mechanical right heart valve.
- Patients who have had cardiac surgery within the last month before enrollment.
- Patients who have an existing atrial lead that will not be replaced.
- Patients with suspected accessory atrial-ventricular pathways.
- Patients classified as New York Heart Association functional classification four (NYHA IV) at time of enrollment.
- Patients who are enrolled in any concurrent drug and/or device study which could confound the results of this study.
