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Ultrasound-Guided Pacemaker Implantation for Slow Heart Rate (RADICAL USE Trial)
N/A
Recruiting
Research Sponsored by Habib Khan
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 during procedure
Awards & highlights
RADICAL USE Trial Summary
This trial is investigating whether ultrasound can be used to guide the implantation of pacemaker leads into the heart, in order to reduce the amount of radiation exposure for both the patient and the doctor.
Who is the study for?
This trial is for adults over 18 who need a single-chamber pacemaker or cardioverter-defibrillator. It's not suitable for individuals with a BMI over 30, pregnant women, those needing more complex devices, people with claustrophobia, chest wall issues like trauma or radiation treatment history, active cancer patients, or those with certain implants that interfere with ultrasound.Check my eligibility
What is being tested?
The study is testing if using ultrasound instead of radiation can be effective in guiding the implantation of leads into the heart during pacemaker placement. This could potentially reduce risks associated with repeated radiation exposure and allow smaller centers to perform these procedures without expensive X-ray equipment.See study design
What are the potential side effects?
Ultrasound use in this context is generally safe and does not have significant side effects. However, there may be minor discomfort from the pressure of the handheld probe used during echocardiography.
RADICAL USE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success of implanting a single chamber lead with use of ultrasound
Secondary outcome measures
Duration of radiation will be measured in seconds
Total radiation dose will be collected in centiGray and milliGray units.
RADICAL USE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced fluoroscopy armExperimental Treatment1 Intervention
Patients exposed to 20 seconds or less of fluoroscopy to implant a single chamber device with aid of ultrasound / echocardiography.
Group II: Conventional armActive Control1 Intervention
Patients exposed to more than 20 seconds of fluoroscopy to implant a single chamber device with/without the aid of ultrasound / echocardiography.
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Who is running the clinical trial?
Habib KhanLead Sponsor
2 Previous Clinical Trials
304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.You are scared of being in small or enclosed spaces.I currently have cancer.I have pain in my chest wall or had an injury there.You can have a specific type of heart device called a single chamber pacemaker or single chamber cardioverter-defibrillator.Your body mass index (BMI) is higher than 30.You have a dual-chamber or CRT device implanted.You have medical devices or tools from previous surgeries that might make it hard to get clear ultrasound images.I have had radiation therapy to my chest for cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Reduced fluoroscopy arm
- Group 2: Conventional arm
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 there an ongoing recruitment process for this trial?
"Affirmative. Clinicaltrials.gov has published that this medical trial is currently enrolling patients; the initial post date was July 30th 2021 and it just underwent a renewal on October 2nd 2022."
Answered by AI
How many participants are included in this trial?
"Affirmative, the clinicaltrials.gov website shows that this research is currently seeking participants. The initial listing was made on July 30th 2021 and has been amended as recently as October 2nd 2022. In total, 66 individuals are needed to take part in this trial at a single location."
Answered by AI
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