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

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.

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Key information

Conditions

Sinus Node Dysfunction Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill/Bicycle exercise testing

Diagnostic Test

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

Primary outcomes

Change in heart rate from baseline to Day 30

Time frame: Day 1, Day 30

Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion

Secondary outcomes

Greater heart response with CLS compared to predicted accelerometer based heart rate response

Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 26, 2018
Registry last updated: Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed