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

Part of paid clinical trials in Wilkes-Barre, Pennsylvania.

Sponsor
Geisinger Clinic
Study ID
NCT05646251
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Heart Ultrasound — DEVICE
    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.

Study Details

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: 1. Does this help the doctors with figuring out the wire location during implantation? 2. Does this reduce the wire placement procedure time? 3. Does this reduce the x-ray imaging time during the procedure? Participants will be asked to: 1. Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant. 2. Have a urine pregnancy test (if applicable) 3. Have a heart ultrasound during implant procedure 4. Answer questions related to heart failure symptoms to see what stage of heart failure is present 5. 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.

Key Dates

Start date
Mar 1, 2023
Status verified
Sep 2025
Primary completion
Jun 24, 2024
Completion
Oct 27, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EC-LBBAP Participant
    A heart ultrasound will be used during a pacemaker implant procedure
  • No Intervention: Control participant
    A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.
  • Experimental: ECLBBAP handheld participant
    A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure

Primary Outcome Measure

A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram [ Time Frame: Perioperative, through study completion, an average of 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Geisinger ClinicWilkes-BarrePennsylvania18711-

Find similar trials in Wilkes-Barre, PA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Geisinger Clinic· Wilkes-Barre, PA

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