Sinus Node Dysfunction
Conditions
Brief summary
This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement. Patients with sinus node dysfunction who have previously received a Biotronik pacemaker with His bundle lead placement as part of routine care will be recruited for the study. A hand-grip exercise will be performed at the conclusion of bicycle exercise testing in order to assess the performance of CLS during isometric exercise. After the study exercise testing is completed, data will be collected from the pacemaker.
Interventions
DIAGNOSTIC_TESTTreadmill/Bicycle exercise testing
Exercise testing will be scheduled on the same day as the enrollment visit and within 30 days after post-implant visit. The standard protocol will be typically set at an initial workload of 15Watts and go up by increments of 10 Watts every 3 minutes, as follows: Stage 1 - 15 W Stage 2 - 25 W Stage 3 - 35 W Stage 4 - 45 W
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Documented sinus node dysfunction * Biotronik pacemaker implanted with His bundle lead placement for standard indications * Implanted at least 30 days * CLS has been enabled for at least 7 days or will be programmed ON for at least 7 days prior to exercise test * Leads and device are functioning appropriately
Exclusion criteria
* Inability to complete treadmill/bicycle exercise test * Planned surgical revision or replacement of the device and/or leads * Patients who are unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate from baseline to Day 30 | Day 1, Day 30 | Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Greater heart response with CLS compared to predicted accelerometer based heart rate response | Day 1, Day 30 | CLS rate response will be analyzed individually for each subject by comparing the CLS response, which is collected by the CLS Action Log, to heart rate information. |
Countries
United States
Outcome results
None listed