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Procedure
Ablation Techniques for Atrial Fibrillation (RECONFIRM Trial)
N/A
Recruiting
Led By Sanjiv Narayan, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >21 years
Reported incidence of at least two documented episodes of symptomatic paroxysmal or persistent atrial fibrillation (AF) during the 3 months preceding trial entry (at least one episode documented by 12-lead ECG or ECG rhythm strip). Ideally, patients will have implanted continuous ECG recorders in place for >30 days prior to the procedure to document AF episodes and percentage of time in AF ("burden") prior to ablation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
RECONFIRM Trial Summary
This trial will compare the safety and effectiveness of two treatments for atrial fibrillation: one that uses a special guidance system during ablation and one that doesn't.
Who is the study for?
Adults over 21 with symptomatic atrial fibrillation, stable on medical therapy for 3+ months, and a left atrial diameter ≤5.5cm. Must have had at least two episodes of AF in the last three months and be refractory to one anti-arrhythmic medication. Participants need to agree to anticoagulation post-procedure and not be pregnant or planning pregnancy.Check my eligibility
What is being tested?
The study is testing if adding FIRM (Focal Impulse and Rotor Modulation) to conventional PVI (Pulmonary Vein Isolation) is safer and more effective for treating atrial fibrillation than PVI alone. Patients are randomly assigned to either treatment group.See study design
What are the potential side effects?
Potential side effects include risks associated with ablation procedures such as bleeding, infection, damage to heart structures, blood clots leading to stroke or other issues, arrhythmias, reactions from anesthesia or contrast media used during imaging.
RECONFIRM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 21 years.
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I have had at least two episodes of AF in the last 3 months, confirmed by an ECG.
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My left atrial diameter is 5.5cm or less, confirmed by a heart scan.
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My heart condition didn't improve after taking a specific heart medication.
RECONFIRM Trial 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
Long term success
Secondary outcome measures
Adverse Events
Healthcare Utilization
Long-term freedom from AF/AT
+2 moreRECONFIRM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FIRM-guided ablation plus PVIExperimental Treatment1 Intervention
These patients will be treated by ablation of patient-specific rotors and focal sources (FIRM). Conventional ablation (PVI) will then be performed as part of the standard of care procedure.
Group II: Conventional AF Ablation with PVIActive Control1 Intervention
These patients will be treated by conventional AF ablation by pulmonary vein isolation (PVI) alone.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,235 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
425,525 Patients Enrolled for Atrial Fibrillation
Sanjiv Narayan, MD, PhD3.02 ReviewsPrincipal Investigator - Stanford University
Stanford University
4 Previous Clinical Trials
18 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
16 Patients Enrolled for Atrial Fibrillation
5Patient Review
Dr. Smith was very kind and knowledgeable. I had two procedures done for my atrial fibrillation and have been in rhythm for 18 months!
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 21 years.I have had a heart attack in the last 3 months or have ongoing heart issues.You are not expected to live for at least 12 months, which is the length of the trial.Your heart's pumping function is at least 40%.I have not had a stroke, TIA, or blood clot in the last 6 months.My atrial fibrillation is due to a temporary condition like surgery or thyroid issues.I have had a blood clot in my heart or lungs recently.I have significant heart conditions that could make heart ablation risky.My electrolyte levels are stable enough for an ablation procedure.I have had at least two episodes of AF in the last 3 months, confirmed by an ECG.I have been on blood thinners for over 3 weeks with an INR > 2 if on warfarin.I cannot take blood thinners due to allergies or bleeding issues.My AFib must last more than 10 minutes or be induced for the study.I need blood thinners due to my high stroke risk score.I am scheduled for heart surgery or a transplant within the next year.I have severe and unstable heart failure.I am willing to stay on blood thinners for at least 3 months after my procedure.I have a history of significant blood clotting problems.My heart condition is stable and I've been on the same heart medication for over 3 months.I have a serious lung condition or another illness that makes anesthesia risky for me.You have an allergy to contrast dye that cannot be treated.You have a device in your heart to close a hole or to replace a valve.I am a man, or I am a woman who cannot become pregnant.My left atrial diameter is 5.5cm or less, confirmed by a heart scan.My heart condition didn't improve after taking a specific heart medication.
Research Study Groups:
This trial has the following groups:- Group 1: FIRM-guided ablation plus PVI
- Group 2: Conventional AF Ablation with PVI
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.
How many participants are being recruited for this experiment?
"Affirmative, the clinicaltrials.gov records suggest that this study is actively seeking participants. The listing was initially published April 1st 2016 and has been revised October 31st 2022. Two sites are recruiting a total of 120 patients for the trial."
Answered by AI
Is enrollment currently available for this clinical investigation?
"According to the clinicaltrials.gov portal, this study is actively searching for individuals eligible for participation. The original recruitment post was published on April 1st 2016, and has since been modified as recently as October 31st 2022."
Answered by AI
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