Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change in heart rate from baseline to Day 30
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Closed Loop Stimulation (CLS)
Prior to enrollment, the patient would have received Biotronik pacemaker with His bundle lead placement for at least 30 days and CLS will be programmed ON for at least 7 days as part of routine care.
Intervention: Treadmill/Bicycle exercise testing (Diagnostic Test)
Outcomes
Primary Outcomes
Change in heart rate from baseline to Day 30
Time Frame: Day 1, Day 30
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion
Secondary Outcomes
- Greater heart response with CLS compared to predicted accelerometer based heart rate response(Day 1, Day 30)