BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)
Enrolling By Invitation
18-99 years
All
Phase
N/A
50 participants needed
1 Location
Brief description of study
A
prospective, multinational, randomized, double-blind, clinical trial evaluating
the safety and effectiveness of a new pacemaker program called atrioventricular
interval modulation (AVIM). The sponsor aims to enroll about 500 participants from up to 100
centers worldwide into this study. Participation lasts up
to 37 months.
Detailed description of study
This trial evaluates the safety & effectiveness of a novel AV interval modulation (AVIM) algorithm downloaded into a Medtronic pacemaker. The study has 3 phases: 1) Screening/Run-in, 2) Double-blind Randomized, 3) Randomized unblinded. Patients within 90 days of de novo implant of an Astra/Azure pacemaker also having uncontrolled hypertension may be included in this study. During the Double-blind Randomized Phase, subjects in the control group will receive SOC pacemaker & hypertension therapy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Atrioventricular Interval Modulation, Hypertension
-
Age: Between 18 Years - 99 Years
-
Gender: All
Inclusion
1. Patient has or is indicated for a de novo dual-chamber pacemaker
2. Willing to adhere to the prescribed baseline antihypertension medical regimen during the Eligibility Assessment Phase and for 12 months post-randomization
3. Systolic blood pressure ≥140 mmHg and <180 mmHg
Exclusion
1. Known secondary cause of hypertension
2. Currently in persistent or permanent atrial fibrillation
3. Pulmonary hypertension with systolic pulmonary artery pressure greater than 70mmHg
4. Currently in NYHA Class II or greater heart failure symptoms
Updated on
20 Sep 2024.
Study ID: 856629
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