Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03601754|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sinus Node Dysfunction||Diagnostic Test: Treadmill/Bicycle exercise testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
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
|Contact: April Jacob||212 263 7704||April.Jacob@nyulangone.org|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: April Jacob 212-263-7704 firstname.lastname@example.org|
|Principal Investigator: Chirag Barbhaiya, MD|
|Principal Investigator:||Chirag Barbhaiya, MD||NYU Langone Health|