In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Heart Failure
Biventricular pacing versus Right Ventricular pacing in patients with atrioventircular block (Heart / Heart Failure)
The purpose of this study is to test if pacing both the left and right lower chambers (ventricles) will decrease the number of hospital and clinic visits for heart failure related symptoms, extend subject life or delay how soon subjects experience certain heart failure symptoms as compared to subjects who are paced in only one ventricle (the right ventricle).
Subject has standard class I or class IIa indications for pacemaker implantation in accordance with ACC/AHA/HRS guidelinesb.
Subject has been diagnosed with at least one of the followingc.
Third degree AV block.
Symptomatic or asymptomatic second degree AV block.
First degree AV block with symptoms similar to pacemaker syndrome.
Documented Wenckebach or PR interval = 300 ms when paced at 100 ppm (Refer to Section III.B.2.).
Subject is receiving a first time implant.
Subject is indicated for ICD implantation for the automated treatment of life-
threatening arrhythmiasd (required only if subject will receive a CRT-D device).
Subject has been classified as NYHA functional class I, II or III within 30 days.
prior to study enrollment.
Subject’s most recent documented ejection fraction (by any methodology) within
the past 90 days prior to study enrollment is = 50%9. Subject is at least 18 years old at the time of consent.
Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent.
Subject is able to receive a pectoral implant.
Subject is expected to remain available for follow-up visits at the study center.
Subject is willing and able to comply with the protocol.
Subject has ever had a previous or has an existing IPG, ICD or BiV implant.
Subject has had unstable angina, acute MI, CABG or PTCA within 30 days prior
to study enrollment.
Subject has had a valve replacement or repair within six months (180 days) prior to study enrollment.
Subject has valvular disease and is indicated for valve repair or replacement.
Subject has a mechanical right heart valve6. Subject is indicated for a biventricular pacing device (CRT-P or CRT-D):
a.NYHA functional class III or IV, and Remains symptomatic despite stable optimal medical therapy, and LVEF = 35%, and QRS duration of = 120 ms
Subject is enrolled in a concurrent study that may confound the results of this study (Subject involvement in any concurrent clinical study (including registries) requires approval of the study manager or designeee.).
Subject is pregnant, or of childbearing potential and not on a reliable form of birth control.
Subject status post heart transplant.
Subject has been classified as NYHA functional class IV within 90 days prior to
Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent.