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Pacemaker
LBBAP vs RV Pacemaker for Heart Pacing Issues
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
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 12 months
Awards & highlights
Study Summary
This trial suggests LBBAP is a promising option to prevent LV systolic dysfunction in long-term RV pacing. Left Bundle Branch Area Pacing is a technique to prevent heart failure & desynchrony in patients with AV block. It's up to the proceduralist whether to use it.
Who is the study for?
The Boston Pace Study is for adults over 18 with complete or high-grade AV block expected to need a lot of ventricular pacing, and who have a left ventricular ejection fraction (LVEF) of 50% or more. They must have had an echocardiogram in the last three months. People with past heart muscle issues, recent heart attacks, blocked arteries, serious valve problems, short life expectancy or pregnancy cannot join.Check my eligibility
What is being tested?
This study tests two types of pacemakers: Left Bundle Branch Area Pacemaker (LBBAP), which is newer and might prevent heart muscle problems caused by pacing; and Right Ventricular Pacemaker (RVP), the traditional option. The goal is to see if LBBAP can be a better standard for patients needing frequent ventricular pacing.See study design
What are the potential side effects?
Pacemaker implantation may cause bleeding, infection at the site of surgery, lead displacement requiring repositioning, blood vessel damage during insertion, reaction to anesthesia used during procedure and rarely could cause puncture of the heart muscle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in left ventricular ejection fraction (LVEF)
Change in left ventricular end systolic volume (LVESV)
Secondary outcome measures
All-cause mortality
Cardiovascular mortality
Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision
+15 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Left Bundle Branch Area PacingExperimental Treatment1 Intervention
Group II: Right Ventricular PacingActive Control1 Intervention
Find a Location
Who is running the clinical trial?
MedtronicIndustry Sponsor
607 Previous Clinical Trials
828,575 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,541 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is below normal.I have blocked arteries in my heart.I have had a heart attack before.I have a severe heart block that requires frequent pacing.I have a serious heart valve problem.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Left Bundle Branch Area Pacing
- Group 2: Right Ventricular Pacing
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research still looking for participants?
"Affirmative. The information posted on clinicaltrials.gov shows that the research trial, first published on May 1st 2023, is actively enrolling patients. Two medical centres are looking for 100 individuals to take part in this study."
Answered by AI
How many individuals are involved in the experimental research?
"Affirmative. The information on clinicaltrials.gov verifies that this medical experiment, which was first published May 1st 2023, is still actively searching for volunteers. A total of 100 individuals are necessary to be enrolled from two different research facilities."
Answered by AI
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