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Intra-procedural Transthoracic Echocardiogram for Heart Failure (EC-LBBAP Trial)

N/A
Recruiting
Led By Pugazhendhi Vijayaraman, MD
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether using heart ultrasound during pacemaker implantation is effective in helping doctors accurately place wires and reducing procedure time and radiation exposure.

Who is the study for?
This trial is for patients needing a permanent pacemaker or ICD with conduction system pacing lead for slow heart rate or to coordinate heartbeats. They must be willing to follow the study's procedures and be available throughout its duration. It's not for those who can't consent, are pregnant, or in another study that could affect results.
What is being tested?
The study observes if using a heart ultrasound during pacemaker implantation helps doctors place wires accurately, reduces procedure time, and cuts down on x-ray use. Participants will undergo exams, ECGs, ultrasounds during implantation, and device checks post-implant.
What are the potential side effects?
Since this is an observational study focusing on the process of pacemaker implantation rather than testing new drugs or treatments directly, side effects are related to standard risks of the procedure itself such as discomfort from echocardiograms and potential complications from pacemaker insertion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change of fluoroscopy/procedure duration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EC-LBBAP ParticipantExperimental Treatment1 Intervention
A heart ultrasound will be used during a pacemaker implant procedure
Group II: Control participantActive Control1 Intervention
A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,068 Total Patients Enrolled
92 Trials studying Heart Failure
91,951 Patients Enrolled for Heart Failure
Geisinger ClinicLead Sponsor
155 Previous Clinical Trials
1,978,609 Total Patients Enrolled
5 Trials studying Heart Failure
7,342 Patients Enrolled for Heart Failure
Pugazhendhi Vijayaraman, MDPrincipal InvestigatorGeisinger Clinic
3 Previous Clinical Trials
1,145 Total Patients Enrolled
1 Trials studying Heart Failure
100 Patients Enrolled for Heart Failure

Media Library

EC-LBBAP Participant Clinical Trial Eligibility Overview. Trial Name: NCT05646251 — N/A
Heart Failure Research Study Groups: EC-LBBAP Participant, Control participant
Heart Failure Clinical Trial 2023: EC-LBBAP Participant Highlights & Side Effects. Trial Name: NCT05646251 — N/A
EC-LBBAP Participant 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646251 — N/A
~0 spots leftby Jan 2025
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