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Fluoroless Electroanatomic Mapping for Heart Block

N/A

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for a period of 6 months post procedure

Awards & highlights

Study Summary

This trialtests a new way to pace the heart safely and accurately with less radiation exposure than the usual method.

Who is the study for?

This trial is for adults over 18 who need a pacemaker or cardiac resynchronization therapy device due to conditions like heart failure or various types of heart block. It's not for those already with such devices, unable to consent, pregnant, or with follow-up issues.Check my eligibility

What is being tested?

The study compares two methods of placing pacing devices: one uses electroanatomic mapping (EAM) without X-rays (fluoroless), and the other uses conventional X-ray guidance. The safety and accuracy of these techniques are being evaluated.See study design

What are the potential side effects?

Potential side effects may include discomfort at the implant site, infection risk from the procedure, possible allergic reactions to materials used in either technique, and rare complications related to device placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for a period of 6 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for a period of 6 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and for a period of 6 months post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Success of achieving CSP

Secondary outcome measures

Need for His Lead revisions

Procedure-related complications

Interventional procedure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping systemExperimental Treatment1 Intervention

Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure.

Group II: Conventional Conduction System Pacing(CSP) using fluoroscopyPlacebo Group1 Intervention

Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

423 Previous Clinical Trials

164,103 Total Patients Enrolled

Media Library

Conventional fluoroscopy guided Conduction System Pacing(CSP) Clinical Trial Eligibility Overview. Trial Name: NCT03903107 — N/A

Sinus Node Dysfunction or Sick Sinus Syndrome Research Study Groups: Conventional Conduction System Pacing(CSP) using fluoroscopy, Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system

Sinus Node Dysfunction or Sick Sinus Syndrome Clinical Trial 2023: Conventional fluoroscopy guided Conduction System Pacing(CSP) Highlights & Side Effects. Trial Name: NCT03903107 — N/A

Conventional fluoroscopy guided Conduction System Pacing(CSP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03903107 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for patients to join this investigation?

"This medical study, which was originally posted on October 26th 2020 and last updated on December 8th 2022, is not currently open for participant recruitment. However, 55 other trials are actively seeking patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Fluoroless-CSP Trial Using Electroanatomic Mapping

Parikshit Sharma 2020. "The Fluoroless-CSP Trial Using Electroanatomic Mapping". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03903107.