NCT03601754

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinus Node Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-19
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-07-26
• Last updated: 2019-11-18

Locations

1 site across 1 country: United States