Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 7/28/2018 |
| Start Date: | July 19, 2018 |
| End Date: | June 2019 |
| Contact: | Jessica Holzman |
| Email: | Jessica.Holzman@nyumc.org |
| Phone: | 212-263-9977 |
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.
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.
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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Chirag Barbhaiya, MD
Phone: 212-263-9977
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