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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

EC-LBBAP Trial 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.Check my eligibility

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.See study design

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.

EC-LBBAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

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

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

Primary outcome measures

A positive success rate of LBBAP utilization with intraprocedural transthoracic echocardiogram

Change of fluoroscopy/procedure duration

Identification of work-flow and echocardiographic windows to facilitate LBBAP

EC-LBBAP 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

MedtronicIndustry Sponsor

607 Previous Clinical Trials

828,655 Total Patients Enrolled

90 Trials studying Heart Failure

90,774 Patients Enrolled for Heart Failure

Geisinger ClinicLead Sponsor

149 Previous Clinical Trials

1,886,115 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

Frequently Asked Questions

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

Are adults aged 25 and above eligible to participate in this experimental research?

"According to the prerequisites for this study, applicants must be between 18 and 89 years of age."

Answered by AI

What are the entry requirements for participating in this clinical experiment?

"This clinical trial seeks to recruit 20 individuals with a diagnosis of heart failure who are between the ages of 18 and 89."

Answered by AI

Can the general public currently enroll in this clinical experiment?

"According to information provided on clinicaltrials.gov, this medical project is not actively recruiting patients at the moment. It was first posted in mid January 2023 and its last update occurred early December 2022. Yet for those seeking clinical trial participation, there are 714 other studies which are currently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)

2023. "Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05646251.