Investigating whether ultrasound stimulation can be used to reset or regulate the heart’s rhythm in patients with heart failure

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy (CRT) in patients with heart failure; Circulatory System

• Registration Number: ISRCTN11165621
• Lead Sponsor: Medtronic, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Study Completion: 2021-05-03
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Meets standard criteria for implantation of a CRT-P or CRT-D device according to local guidelines
2. Subject (or legally authorized representative) has signed and dated the Informed Consent Form
3. Aged 18 years or older

Exclusion Criteria

1. Confirmed myocardial damage, cardiac or chest surgery, or coronary procedure within the previous 30 days
2. Enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
3. Pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the PACE-US Procedure visit.
4. Meets exclusion criteria required by local law (e.g. age, etc.)
5. Has any medical condition that would limit study participation per physician discretion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve successful pacing, defined as heart capture observed on the ECG for at least three consecutive beats after ultrasonic pacing stimuli are delivered to at least one pacing location. Descriptive statistics will be used to summarize the number of captured beats. The number and percent of subjects with a successful pacing outcome will be reported. All Procedure cohort subjects who complete enrollment and for whom at least one acoustic window is found will be included in the analysis.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Successful resynchronization event, defined as normalization of the QRS duration and electrical dyssynchrony index assessed using CardioInsight electrical activation maps at any time point during Ultrasound Stimulation testing<br> 2. Cardiac Troponin I level in blood at baseline and at 4-8hrs or 24-48hrs after Ultrasound Stimulation testing for the subjects assigned to the Procedure cohort or at baseline and at 4-8hrs or 24-48hrs after baseline for the subjects assigned to the Control cohort<br>