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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sinus Node Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Treadmill/Bicycle exercise testing

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No