Heart Failure
Conditions
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: 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.
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). Twenty patients will undergo intraprocedural transthoracic echocardiogram via standard practices. An additional 10 patients will undergo intraprocedural transthoracic echocardiogram using a hand-held ultrasound device. The study team will compare the difference in procedural success between case and control patients.
Interventions
DEVICEHeart Ultrasound
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.
Sponsors
Medtronic
Geisinger Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Twenty patients will undergo intraprocedural transthoracic echocardiogram via standard practices. An additional 10 patients will undergo intraprocedural transthoracic echocardiogram using a hand-held ultrasound device. The study team will retrospectively identify 30 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram | Perioperative, through study completion, an average of 3 months | Positive success rate of LBBAP is measured by Left bundle branch capture for participants, measured during implant |
| Difference of Fluoroscopy/Procedure Duration Between Groups | Perioperative | Difference in fluoroscopy and procedure duration using echo guided LBBAP lead implantation compared to control data for standard LBBAP lead implantation |
| Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures | Through study completion, an average of 3 months | This measure is to determine if the workflow is feasible in regular practice (echo tech availability, lab availability, duration of comparative procedures) between intervention group and controls, and to determine if the identifying echocardiographic windows is able to be performed pre operatively on all intervention patients This measure is to determine the number of participants that the workflow is feasible for and could be performed on in regular practice (echo tech availability, lab availability, duration of comparative procedures) |
Countries
United States
Participant flow
Recruitment details
Potential participants will be identified by clinician referrals at Geisinger Wyoming Valley Heart Hosptial. Research staff will contact potential subjects and invite them to participate.
Pre-assignment details
21 EC-LBBAP participants were consented and enrolled in the study. One participant did not complete the study and was exited, as echo was unable to be complete at implant. 12 EC-LBBAP handheld participants were consented and enrolled in the study. Two participants did not complete the study and were exited, as echo was unable to be complete at implant. 30 Participants in the Control Arm/Group are not considered enrolled and therefore, not included in the Number Enrolled.
Participants by arm
| Arm | Count |
|---|---|
| EC-LBBAP Participant A heart ultrasound will be used during a pacemaker implant procedure | 20 |
| Control Participant A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm. | 30 |
| ECLBBAP Handheld Participant A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure | 10 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | EC-LBBAP Participant | Total | ECLBBAP Handheld Participant | Control Participant |
|---|---|---|---|---|
| Age, Continuous | 71.35 years STANDARD_DEVIATION 10.236 | 74.45 years STANDARD_DEVIATION 10.31 | 72.8 years STANDARD_DEVIATION 12.5 | 77.06 years STANDARD_DEVIATION 9.18 |
| Atrial Fibrillation | 15 Participants | 41 Participants | 5 Participants | 21 Participants |
| BMI | 29.8 kg/m^2 STANDARD_DEVIATION 5.63 | 28.8 kg/m^2 STANDARD_DEVIATION 5.58 | 26.9 kg/m^2 STANDARD_DEVIATION 6.48 | 28.74 kg/m^2 STANDARD_DEVIATION 5.27 |
| Cardiomyopathy | 7 Participants | 33 Participants | 5 Participants | 21 Participants |
| Coronary artery disease | 9 Participants | 24 Participants | 3 Participants | 12 Participants |
| Diabetes | 5 Participants | 20 Participants | 5 Participants | 10 Participants |
| Hypertension | 17 Participants | 55 Participants | 10 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 20 Participants | 58 Participants | 10 Participants | 28 Participants |
| Sex: Female, Male Female | 10 Participants | 25 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 10 Participants | 35 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 30 | 0 / 10 |
| other Total, other adverse events | 0 / 20 | 0 / 30 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 30 | 0 / 10 |
Outcome results
Primary
A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram
Positive success rate of LBBAP is measured by Left bundle branch capture for participants, measured during implant
Time frame: Perioperative, through study completion, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EC-LBBAP Participant | A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram | 19 Participants |
| EC-LBBAP Handheld Participant | A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram | 10 Participants |
Primary
Difference of Fluoroscopy/Procedure Duration Between Groups
Difference in fluoroscopy and procedure duration using echo guided LBBAP lead implantation compared to control data for standard LBBAP lead implantation
Time frame: Perioperative
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| EC-LBBAP Participant | Difference of Fluoroscopy/Procedure Duration Between Groups | Procedure duration | 101 min | Standard Deviation 27 |
| EC-LBBAP Participant | Difference of Fluoroscopy/Procedure Duration Between Groups | Fluoroscopy duration | 8.9 min | Standard Deviation 7.9 |
| EC-LBBAP Handheld Participant | Difference of Fluoroscopy/Procedure Duration Between Groups | Procedure duration | 89 min | Standard Deviation 29 |
| EC-LBBAP Handheld Participant | Difference of Fluoroscopy/Procedure Duration Between Groups | Fluoroscopy duration | 10.1 min | Standard Deviation 6.5 |
| Standard LBBP | Difference of Fluoroscopy/Procedure Duration Between Groups | Procedure duration | 95 min | Standard Deviation 39 |
| Standard LBBP | Difference of Fluoroscopy/Procedure Duration Between Groups | Fluoroscopy duration | 13.5 min | Standard Deviation 8.5 |
Primary
Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures
This measure is to determine if the workflow is feasible in regular practice (echo tech availability, lab availability, duration of comparative procedures) between intervention group and controls, and to determine if the identifying echocardiographic windows is able to be performed pre operatively on all intervention patients This measure is to determine the number of participants that the workflow is feasible for and could be performed on in regular practice (echo tech availability, lab availability, duration of comparative procedures)
Time frame: Through study completion, an average of 3 months
Population: Workflow defined and echo images obtained to facilitate LBBAP in participants in the ECLBBAP arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EC-LBBAP Participant | Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures | 20 participants |
| EC-LBBAP Handheld Participant | Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures | 10 participants |