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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Ultrasound
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patient with indication for permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) utilizing conduction system pacing lead for bradycardia or cardiac resynchronization therapy patient is willing to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Inability to provide informed consent pregnant enrolled in a concurrent study that may confound the results of this study

Sites / Locations

  • Geisinger ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EC-LBBAP Participant

Control participant

Arm Description

A heart ultrasound will be used during a pacemaker implant procedure

A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.

Outcomes

Primary Outcome Measures

A positive success rate of LBBAP utilization with intraprocedural transthoracic echocardiogram
Change of fluoroscopy/procedure duration
Change using LBBAP lead implantation compared to historic data from prior Geisinger studies utilizing LBBAP
Identification of work-flow and echocardiographic windows to facilitate LBBAP

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
July 18, 2023
Sponsor
Geisinger Clinic
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT05646251
Brief Title
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Acronym
EC-LBBAP
Official Title
Intra-procedural Transthoracic EChocardiogram to Facilitate LBBAP
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
January 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. The main questions this aims to answer are: Does this help the doctors with figuring out the wire location during implantation? Does this reduce the wire placement procedure time? Does this reduce the x-ray imaging time during the procedure? Participants will be asked to: Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant. Have a urine pregnancy test (if applicable) Have a heart ultrasound during implant procedure Answer questions related to heart failure symptoms to see what stage of heart failure is present Have device interrogation (a wand placed over the chest to see that the device is working properly) at a visit 2 weeks post implant and at 3 months post implant.
Detailed Description
The EC-LBBAP study is a prospective, single-enter, observational research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of echocardiogram guided LBBAP lead implantation. Eligible patients will undergo LBBAP using Medtronic 3830 lead and C315His sheath. LBBAP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak Left Ventricular Pacing (LV) activation time and lead depth in the 2D transthoracic echo at implant. During implant procedure, transthoracic echo windows will be identified and documented: Parasternal short and long axis, apical 2 and 4 chamber views and subcostal views to visualize the proximal interventricular septum. Following venous access using cephalic vein cut-down or ultrasound guided axillary vein access, the lead implantation in the left bundle branch region will be guided by echocardiography. Retrospectively, the study team will identify 20 consecutive previous patients who satisfy inclusion and exclusion criteria (control patients). The study team will compare the difference in procedural success between case and control patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EC-LBBAP Participant
Arm Type
Experimental
Arm Description
A heart ultrasound will be used during a pacemaker implant procedure
Arm Title
Control participant
Arm Type
No Intervention
Arm Description
A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.
Intervention Type
Device
Intervention Name(s)
Heart Ultrasound
Intervention Description
A wand is placed on the chest to use soundwaves to make a picture of the heart and shows how the muscle and valves work. This helps with device placement.
Primary Outcome Measure Information:
Title
A positive success rate of LBBAP utilization with intraprocedural transthoracic echocardiogram
Time Frame
15 Months
Title
Change of fluoroscopy/procedure duration
Description
Change using LBBAP lead implantation compared to historic data from prior Geisinger studies utilizing LBBAP
Time Frame
15 Months
Title
Identification of work-flow and echocardiographic windows to facilitate LBBAP
Time Frame
15 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with indication for permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) utilizing conduction system pacing lead for bradycardia or cardiac resynchronization therapy patient is willing to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Inability to provide informed consent pregnant enrolled in a concurrent study that may confound the results of this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pugazhendhi Vijayaraman, MD
Phone
570-808-6020
Email
pvijayaraman1@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pugazhendhi Vijayaraman, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Clinic
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pugazhendhi Vijayaraman, MD
Phone
570-808-6020
Email
pvijayaraman1@geisinger.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared in an identifiable way.

Learn more about this trial

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

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