Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement

NYU Langone Health

Status: Completed

Conditions: Sinus Node Dysfunction

Treatments: Diagnostic Test: Treadmill/Bicycle exercise testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03601754

18-00143

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Closed Loop Stimulation (CLS)

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Treadmill/Bicycle exercise testing