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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03601754

Collaborator

(none)

Enrollment

Location

Arm

6.4

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sinus Node Dysfunction	Diagnostic Test: Treadmill/Bicycle exercise testing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 19, 2018

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Closed Loop Stimulation (CLS) Prior to enrollment, the patient would have received Biotronik pacemaker with His bundle lead placement for at least 30 days and CLS will be programmed ON for at least 7 days as part of routine care.	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

Arm

Intervention/Treatment

Experimental: Closed Loop Stimulation (CLS)

Prior to enrollment, the patient would have received Biotronik pacemaker with His bundle lead placement for at least 30 days and CLS will be programmed ON for at least 7 days as part of routine care.

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

Outcome Measures

Primary Outcome Measures

Change in heart rate from baseline to Day 30 [Day 1, Day 30]
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Chirag Barbhaiya, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03601754

Other Study ID Numbers:

18-00143

First Posted:

Jul 26, 2018

Last Update Posted:

Nov 18, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sick Sinus Syndrome

Study Results

No Results Posted as of Nov 18, 2019