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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
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.
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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
1,978,678 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker or Implantable Cardioverter Defibrillator (ICD) for heart rhythm issues.I am willing and able to follow all study rules and attend all visits.
Research Study Groups:
This trial has the following groups:- Group 1: EC-LBBAP Participant
- Group 2: Control participant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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