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

Completed · Not applicable

Conditions studied: Sinus Node Dysfunction

In brief

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.

Key facts

Study ID

NCT03601754

Run by

NYU Langone Health

People needed

5

Starts

2018-07-19

Expected to finish

2019-01-31

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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