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Trial record 8 of 70 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"

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

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ClinicalTrials.gov Identifier: NCT03601754
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : July 19, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601754


Contacts
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Contact: April Jacob 212 263 7704 April.Jacob@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: April Jacob    212-263-7704    april.jacob@nyulangone.org   
Principal Investigator: Chirag Barbhaiya, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Chirag Barbhaiya, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03601754     History of Changes
Other Study ID Numbers: 18-00143
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease
Pathologic Processes