Reduction of Myopotential Interference With Smart Pass in S-ICD Patients

Conditions

• Myopotential Interference
• Subcutaneous ICD

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Smart Pass ON — DEVICE
  Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
• Smart Pass OFF — DEVICE
  Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.

Study Details

This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

Key Dates

Start date

Nov 6, 2023

Status verified

Jan 2026

Primary completion

Dec 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

71 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• Active Comparator: Smart Pass ON
  Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
• Placebo Comparator: Smart Pass OFF
  Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.

Primary Outcome Measure

The incidence of myopotential interference [ Time Frame: throughout the intervention, approximately 20 minutes ]

Central Contacts

• Debi Everidge
  843-792-2944
  [email protected]
• Kavin Panneerselvam
  843-792-0464
  [email protected]

Locations (1)

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