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

Not Applicable

Completed

• Conditions: Sinus Node Dysfunction
• Interventions: Diagnostic Test: Treadmill/Bicycle exercise testing

• Registration Number: NCT03601754
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-02
• Study Start: 2018-07-19
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed Loop Stimulation (CLS)	Treadmill/Bicycle exercise testing	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States