BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.
Inclusion Criteria:
Exclusion Criteria:
sevans@orchestrabiomed.com917-670-5933
astagg@orchestrabiomed.com
Washington D.C., District of Columbia 20010, United States
Celebration, Florida 34747, United States
Wichita, Kansas 67226, United States
Bloomington, Minnesota 55425, United States
Albuquerque, New Mexico 87110, United States
Doylestown, Pennsylvania 18901, United States
Lynchburg, Virginia 24501, United States
Frankfurt, Germany
Katowice, Poland
Southhampton, United Kingdom