Hypertension
Conditions
Interventions
Standard implantation of a dual chamber pacemaker and the activation of the
MOderato-HTN therapy.
Sponsors
BackBeat Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subject is >= 18 years of age 2) Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary. 3) Subject has stable (for prior 2 months) regimen of 2 or more maximally tolerated anti-hypertension medications (of different drug classes), which is anticipated to be able to be maintained without changes for 3 months. 4) Subject has office systolic blood pressure measurement > 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is >=150 mmHg. All measures are to be taken prior to morning medication (e.g. 7-10AM). If the average of the two systolic blood pressure measurements is not >=150 mmHg, or one of the BP readings is less than 140 mmHg, a third measurement can be taken, with the same stability criterion applied for study eligibility. 5) Proximity to study center which will permit compliance with study visits for at least 4 months.
Exclusion criteria
Exclusion criteria: 1) Subject has known secondary cause of HTN 2) Subject has a history in the past year of persistent atrial fibrillation or clinically significant paroxysmal atrial fibrillation (clinically significant paroxysmal atrial fibrillation is defined as atrial fibrillation that in the investigators judgment would prevent the delivery of the Backbeat HTN therapy for a significant amount of the time, over 25%). 3) Subject has ejection fraction =15 mm 6) Subject is on dialysis 7) Subject has estimated Glomerular Filtration Rate (GFR) 190 mmHg 16) Subject is currently participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Pacemaker phase A.1. Primary performance endpoint Moderato pacing performance will be evaluated through analysis of 24 hour Holter monitoring recordings. Additionally, the pacemaker performance will be evaluated by temporarily programming the IPG to different modes (including DDD, VVI) with different rate and timing parameters to evaluate appropriate clinical pacemaker performance. A.2. Primary safety endpoint Incidence of device- and treatment-related serious adverse events through the peri-procedural and 3-month follow-up period. B. Hypertension phase B.1. Primary performance endpoint Moderato - HTN device performance will be evaluated through analysis of 24 hour Holter monitoring recordings. B.2. Primary safety endpoint Incidence of device- and treatment-related serious adverse events through 3 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the above noted endpoints, the additional endpoints listed below will be measured. For each of these parameters, the baseline values determined at the visit just prior to initiation of the Moderato-HTN therapy will be compared to the final values determined at the 3 month visit. The one exception to this is that the baseline echocardiogram will be the one obtained during the original study screening period. • Change in average diastolic blood pressure after 3 months of treatment • Change in the daytime-nighttime difference in BP after 3 months of treatment • Change in the average nighttime BP after 3 months of treatment • Change in left ventricular ejection fraction (by echocardiography) after 3 months of treatment • Changes in proteinuria after 3 months of treatment • Incidence of the occurrence of *pacemaker syndrome* • Changes in serum neurohormone levels (BNP) • Incidence of device malfunction | — |
Countries
Netherlands
Outcome results
None listed