Recruiting

Tetanizing Burst Therapy

Sponsor:

EP Sciences

Code:

NCT03628911

Conditions

Cardiac Electrophysiology

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tetanizing Burst Therapy

Study Details

Brief summary:

This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks

Conditions

Cardiac Electrophysiology

Study ID

NCT03628911

Start date

Jan 1, 2018

Status verified date

Sep, 2019

Completion date

Dec 1, 2020

Anticipated

Primary completion date

Sep 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female age 18-80 years, inclusive
  • Ability to understand and provide written informed consent
  • Normal sinus rhythm
  • Standard transvenous left-sided ICD referred for device replacement due to end of battery life

Exclusion Criteria:

  • Heart rate <40 or >90 bpm
  • Atrial fibrillation or pacemaker dependent
  • NYHA Class III/IV symptoms of HF
  • MI within 90 days of enrollment
  • Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
  • History stroke or TIAs
  • History of prior ICD pocket infection
  • ICD lead resistance that is too high or too low in the opinion of the investigator
  • Female who is pregnant or breastfeeding
  • Prior heart transplant
  • Serum electrolytes out of normal range at participating institution

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Tetanizing Burst Therapy

Tetanizing Burst Therapy tetanizes skeletal muscle with a brief burst of stimulation prior to ICD shock, thereby reducing muscular contraction due to the shock

Primary outcome measure

  • Less pain after TBT impulse with ICD shock compared to ICD shock alone [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

Jane Wilson

8457218210janew@databean.com

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Michele Martucci, RN

410-502-0517mmill148@jhmi.edu

Kathy Avara

410-502-5616kavara1@jhmi.edu

Principal Investigator:

Ronald Berger, MD

More Information

Sponsor

EP Sciences

Last update posted

Sep 17, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by EP Sciences on 2019-09-17.