Your session is about to expire
← Back to Search
Device
Hybrid Ablation for Atrial Fibrillation
N/A
Recruiting
Led By David Huang, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Awards & highlights
Study Summary
This trial will compare two different ways to treat people with asymptomatic/subclinical atrial fibrillation after ablation.
Who is the study for?
This trial is for adults with persistent atrial fibrillation, which lasts more than 7 days but less than a year. They must be planning their first AF ablation and have or get a Biotronik ICM implant at the time of ablation. It's not for those with paroxysmal, long persistent, or permanent atrial fibrillation, severe heart failure, major organ failures, electrolyte problems, intra-cardiac thrombus (unless treated), life expectancy under 1 year, pregnant/nursing women or those unable to consent.Check my eligibility
What is being tested?
The study compares two strategies to manage asymptomatic/subclinical atrial fibrillation after an ablation procedure using data from the Biotronik Insertable Cardiac Monitor (BioMonitor3®). The goal is to see which strategy works better in controlling heart rhythm post-ablation.See study design
What are the potential side effects?
While specific side effects are not listed for this trial involving monitoring devices like BioMonitor3®, general risks may include discomfort at the insertion site, infection risk from the implant procedure and potential allergic reactions to device materials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atrial fibrillation (AF) burden defined as the mean amount of time spent in AF over a pre-specified period of time (excluding short AF episodes of ≤30 seconds) by the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).
Secondary outcome measures
Atrial Flutter or Tachycardia.
Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.
Incidence of repeat procedures.
+7 moreTrial Design
2Treatment groups
Active Control
Group I: Conventional AF ManagementActive Control1 Intervention
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
Group II: Biotronik ICM-guided AF managementActive Control1 Intervention
ICM obtained data will be actively used to guide and monitor treatment .
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
836 Previous Clinical Trials
518,003 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
5,156 Patients Enrolled for Atrial Fibrillation
Biotronik, Inc.Industry Sponsor
38 Previous Clinical Trials
54,694 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
3,418 Patients Enrolled for Atrial Fibrillation
David Huang, MDPrincipal Investigator - University of Rochester
Mayo Clinic Rochester, Mayo HIV Clinic - Rochester
University Of Minnesota Medical Sch-Minneapolis (Medical School)
University Hi-J A Burns School Medicine (Residency)
3 Previous Clinical Trials
4,996 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.Your left atrial (heart) diameter is 60 millimeters or more.I am scheduled for my first AF ablation and will have a Biotronik ICM implant.I cannot undergo certain heart procedures or take specific heart medications due to other health issues.I have heart failure that currently prevents me from undergoing certain heart procedures, but treatment may make me eligible later.I have permanent atrial fibrillation.You have a pacemaker or defibrillator already implanted in your body.I have a serious illness and am expected to live less than a year.I have a blood clot in my heart but might be treated for it.I have had atrial fibrillation for more than a year without stopping.I have had atrial fibrillation lasting more than a week but less than a year.I have episodes of irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional AF Management
- Group 2: Biotronik ICM-guided AF management
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 current participant cap for this research project?
"Biotronik, Inc. needs to recruit 90 eligible participants in order to launch the trial and is using Michigan Heart PC (Ypsilanti) and Rochester Regional Health (Tupelo) as locations for enrolment."
Answered by AI
Is this investigation currently enrolling participants?
"Affirmatively, clinicaltrials.gov hosts data which alludes to this medical experiment recruiting participants. As of September 6th 2022, when the study was last updated, 90 individuals were needed from 4 different sites since it was first posted on June 25th 2020."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger