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Procedure
His Bundle Pacing for Heart Failure (MAP HIS HF Trial)
N/A
Recruiting
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old and not pregnant
Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at three-month follow-up
Awards & highlights
MAP HIS HF Trial Summary
This trial will study the effects of electrical pacing on the heart, specifically in heart failure patients with left bundle branch block. They will use an electro-anatomical mapping system during implantation to study the results.
Who is the study for?
This trial is for heart failure patients with left bundle branch block who are getting an Abbott pacemaker or CRT device. They should have a wide QRS complex on ECG, typical LBBB morphology, NYHA Class II-IV symptoms, LV EF under 50%, and be at least 18 years old. Pregnant women or those planning pregnancy during the study can't join.Check my eligibility
What is being tested?
The study tests mapping and pacing of the His Bundle to correct electrical dyssynchrony in heart failure patients with left bundle branch block. It's a single-arm trial assessing if this method or combined His Bundle plus LV pacing improves heart function.See study design
What are the potential side effects?
Potential side effects may include discomfort from the guidewire placement in the coronary sinus, risks associated with pacemaker or CRT device implantation like infection, bleeding, lead displacement, and possible need for reoperation.
MAP HIS HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and not pregnant.
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I am a woman who can have children, have a recent negative pregnancy test, and use birth control.
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I am getting an Abbott pacemaker or CRT device for my heart condition.
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My heart's pumping ability is below normal.
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I have heart failure with moderate to severe symptoms.
MAP HIS HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at three-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at three-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful HB pacing sites
Secondary outcome measures
Capture threshold of HB pacing
Echocardiographic measurements of LV ejection fraction
Echocardiographic measurements of LV end-systolic volume
+4 moreMAP HIS HF Trial Design
1Treatment groups
Experimental Treatment
Group I: Mapping and Pacing the His BundleExperimental Treatment2 Interventions
All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
404,465 Total Patients Enrolled
124 Trials studying Heart Failure
51,966 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain heart conditions called non-specific intraventricular conduction delay or right bundle branch block.Your ECG shows a wide QRS complex, which means your heart's electrical signals are not normal.You have had surgery to replace your tricuspid valve.I am over 18 and not pregnant.I am a woman who can have children, have a recent negative pregnancy test, and use birth control.I am getting an Abbott pacemaker or CRT device for my heart condition.My heart's pumping ability is below normal.I have heart failure with moderate to severe symptoms.You have a heart device with three or more permanent leads implanted in the past.You have had surgery to repair or replace your aortic valve.I haven't had a heart attack or other major heart issues in the last 3 months.Your ECG shows a specific type of abnormal heart rhythm called complete LBBB.
Research Study Groups:
This trial has the following groups:- Group 1: Mapping and Pacing the His Bundle
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.
What is the scope of subjects receiving treatment in this experiment?
"Affirmative, the information available on clinicaltrials.gov confirms that recruitment is still ongoing for this medical trial which has been posted since March 20th 2019 and last modified April 5th 2022. Only 30 potential participants are needed from one location."
Answered by AI
Are there vacancies available for prospective participants in this investigation?
"Correct. Evident on clinicaltrials.gov, this medical research project is presently enrolling participants. Originally published on March 20th 2019, it was last amended April 5th 2022 and requires 30 patients from one healthcare facility to complete the trial."
Answered by AI
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