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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03601754
Other study ID # 18-00143
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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