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

NCT03601754 | Completed

• 1 other identifier: 18-00143
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Node Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 1, Day 30

Study Arms (1)

Closed Loop Stimulation (CLS)

EXPERIMENTAL

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

Interventions

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

Closed Loop Stimulation (CLS)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chirag Barbhaiya, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: July 26, 2018
• Study Start: July 19, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (1)