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

Primary Purpose

Sinus Node Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill/Bicycle exercise testing
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sinus Node Dysfunction

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed Loop Stimulation (CLS)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in heart rate from baseline to 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
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.

Full Information

First Posted
May 2, 2018
Last Updated
November 14, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03601754
Brief Title
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
Official Title
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed Loop Stimulation (CLS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Treadmill/Bicycle exercise testing
Intervention Description
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 Outcome Measure Information:
Title
Change in heart rate from baseline to Day 30
Description
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion
Time Frame
Day 1, Day 30
Secondary Outcome Measure Information:
Title
Greater heart response with CLS compared to predicted accelerometer based heart rate response
Description
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.
Time Frame
Day 1, Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chirag Barbhaiya, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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