Sinus Node DysfunctionNCT03601754
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
A study testing Treadmill/Bicycle exercise testing in people with Sinus Node Dysfunction, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sinus Node Dysfunction
- What is being tested?
- Treadmill/Bicycle exercise testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Treadmill/Bicycle exercise testing
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill/Bicycle exercise testingDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Treadmill/Bicycle exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate from baseline to Day 30
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion
Measured: Day 1, Day 30
Secondary outcomes (1)
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.
Measured: Day 1, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start19 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node DysfunctionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chirag Barbhaiya, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601754
- Sponsor's protocol ID
- 18-00143
- Status last verified
- Nov 2019
- First submitted
- 2 May 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
- ClinicalTrials.gov ID
- NCT03601754
- Acronym / sponsor ID
- 18-00143
- Conditions
- Sinus Node Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed Loop Stimulation (CLS) | Experimental | Diagnostic Test: Treadmill/Bicycle exercise testingPrior 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill/Bicycle exercise testingExercise 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 | Diagnostic test | Closed Loop Stimulation (CLS) |
Primary outcome
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
1 secondary outcome
Greater heart response with CLS compared to predicted accelerometer based heart rate response
Time frame: Day 1, Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chirag Barbhaiya, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill/Bicycle exercise testing in people with Sinus Node Dysfunction, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate from baseline to Day 30 (time frame: Day 1, Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.