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

Sinus Node Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601754
• Other study ID #: 18-00143
• Status: Completed
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Diagnostic Test:
• Treadmill/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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate from baseline to Day 30	Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion	Day 1, Day 30
Secondary	Greater heart response with CLS compared to predicted accelerometer based heart rate response	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.	Day 1, Day 30