In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Heart / Ventricular Pacing
Title
Study to determine the long-term effect of right ventricular septal (RVS) vs. RV Apical (RVA) pacing in subjects who require ventricular (lower chamber of the heart) pacing (due to AV conduction disturbance (electrical impulse abnormalities) (Heart)
Description
The Optimize RV Follow-up Study is an interventional, multi-center, post-market trial to determine the long-term effect of right ventricular septal (RVS) vs. RV Apical (RVA) pacing in subjects who require ventricular (lower chamber of the heart) pacing (due to AV conduction disturbance (electrical impulse abnormalities). This study is being done as a follow-up to the Optimize RV clinical trial. The goal of RVS pacing is to improve how the heart contracts when paced in the ventricle. RVA pacing can lead to a non-physiologic (not normal) contraction pattern. This can result in lower than normal hemodynamics (circulating blood) and eventually heart failure. By pacing in the septum, it is possible to better emulate (mimic) the hearts natural contraction pattern.
IRB Number
Pro1888
Inclusion/Notes
INCLUSION:
Subjects that are expected to be RV paced >= 90% of the time.
Subjects with LVEF >= 40% within three months prior to enrollment.
Subject s>= 18 years of age.
Subjects that are indicated for a dual chamber pacemaker.
Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle.
Subjects or legal guardians who are willing and able to sign an informed consent (and authorization to use and disclose health information form).
EXCLUSION:
Subjects indicated for cardiac resynchronization therapy (CRT) (based on ACC/AHA/F68+F69HRS guidelines).
Subjects indicated for an implantable cardiac defribrillator (ICD).
Subjects with permanent AF.
Subejcts with expected managed ventricular pacing (MVP) turned on.
Subjects with a previously implanted pacemaker or ICD, CRT.
Subjects with a MI within three months prior to enrollment.
Subjects that received bypass surgery within three months prior to enrollment.
Subjects that have valve replacement within three months prior to enrollment.
Subjects where a RV lead cannot be placed.
Subjects with a mechanical right heart valve.
Women who are pregnant or nursing.
Subjects with significant co-morbidity preventing study completion.
Subjects with termindal conditions with a life expentancy of less than 24 months.
Participation in another study that would confound the results of this study.
