CLINICAL TRIAL

Treatment for Atrial Fibrillation

Recruiting · 18+ · All Sexes · Rochester, NY

This study is evaluating whether a specific type of heart surgery may help reduce the risk of stroke in patients with atrial fibrillation.

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About the trial for Atrial Fibrillation

Eligible Conditions
Atrial Fibrillation · Persistent Atrial Fibrillation (AF)

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Insertable Cardiac Monitor
DEVICE
Control Group 2
Insertable Cardiac Monitor
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
18 years of age or older
Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Screening: ~3 weeks
Treatment: Varies
Reporting: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes and 11 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of Between enrollment and 15 months..

Number of repeat AF ablation.
BETWEEN ENROLLMENT AND 15 MONTHS.
BETWEEN ENROLLMENT AND 15 MONTHS.
Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.
BETWEEN ENROLLMENT AND 15 MONTHS.
BETWEEN ENROLLMENT AND 15 MONTHS.
Number of cardiac hospitalization.
BETWEEN ENROLLMENT AND 15 MONTHS.
BETWEEN ENROLLMENT AND 15 MONTHS.
Number of symptomatic AF recurrence (regardless of duration).
BETWEEN ENROLLMENT AND 15 MONTHS.
BETWEEN ENROLLMENT AND 15 MONTHS.
Number of Deaths.
BETWEEN ENROLLMENT AND 15 MONTHS.
BETWEEN ENROLLMENT AND 15 MONTHS.
Number of clinically significant (>30 min) atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia) as detected and documented by Biotronik ICM after the performance of the index AF ablation procedure.
BETWEEN ENROLLMENT AND 15 MONTHS (EXCLUDING THE INITIAL 3-MONTH BLANKING PERIOD) (ASSESSED IN A RECURRENT EVENT ANALYSIS).
BETWEEN ENROLLMENT AND 15 MONTHS (EXCLUDING THE INITIAL 3-MONTH BLANKING PERIOD) (ASSESSED IN A RECURRENT EVENT ANALYSIS).
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Who is running the study

Principal Investigator
D. H.
Prof. David Huang, Professor Medicine M&D-Cardiology Div
University of Rochester

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for atrial fibrillation?

There is evidence that antiarrhythmic therapy, with either medications or surgery, can control atrial fibrillation and reduce the risk of future events. Patients with atrial fibrillation are at an increased risk of developing stroke if they have other risk factors for ischemic stroke.

Anonymous Patient Answer

What is the primary cause of atrial fibrillation?

Atrial fibrillation occurs most commonly in elderly individuals without a history of stroke or prior pulmonary embolism and with a normal echocardiogram. The most likely causes of this disease are identifiable by careful inspection of ECGs.

Anonymous Patient Answer

What are common treatments for atrial fibrillation?

The predominant treatment for atrial fibrillation is cardioversion. There is no compelling evidence to support the efficacy of anticoagulant or antiplatelet agents, which have been used predominantly for atrial fibrillation.

Anonymous Patient Answer

What causes atrial fibrillation?

The exact cause of atrial fibrillation is unknown. However, studies have shown that there are many factors that increase the risk of developing atrial fibrillation.

Anonymous Patient Answer

What are the signs of atrial fibrillation?

The signs and symptoms caused by atrial fibrillation depend on the cause, and can range from mild to severe. Most fibrillations are usually asymptomatic. Asymptomatic atrial fibrillation is a relatively common condition and may be associated with silent cerebral infarction. Severe symptoms due to atrial fibrillation may vary depending on the underlying cause, and treatment options. However, atrial fibrillation may be identified by routine physical exams. For example, it may be detected on an electrocardiogram when abnormal electrical activity is detected.

Anonymous Patient Answer

How many people get atrial fibrillation a year in the United States?

AF is a common condition in the US. Nearly 1 in 3 adults have AF at some point during their lifetimes. While the average age of onset of AF is not changing, it is important to note that AF is not a disease, since it is asymptomatic for most people.

Anonymous Patient Answer

Can atrial fibrillation be cured?

Cardiological management of AF can improve clinical outcomes independent of left bundle branches block on the implantable cardioverter defibrillator lead. A single antiarrhythmic agent appears effective in long-term AF management.

Anonymous Patient Answer

What is atrial fibrillation?

AF, the most common heart rhythm alteration, is caused by abnormal electrical activity of the heart. Specifically, it is caused by two mechanisms, namely, atrial tachycardia and atrial fibrillation. It is not uncommon that patients complain about the sudden onset and deterioration of the heart rhythm alteration. Furthermore, this is the first time that AF may be diagnosed through the heart rhythm of a patient. We advise the general population and health care providers to be able to diagnose AF correctly and to reduce the incidence of this disease. For this, further researches should be performed in the future.

Anonymous Patient Answer

Is treatment safe for people?

The risks of a treatment decision have to be taken into account in addition to the consequences of a treatment decision. In people with cardioembolic AF, treatment has no measurable impact on cardiovascular events, on survival or on hospital admissions but the decision not to offer treatment has a significant impact on quality of life. When considering anticoagulation in a patient with AF, clinicians should keep in mind that AF patients are older and have comorbidities and should choose treatment which is best for each individual patient.

Anonymous Patient Answer

Who should consider clinical trials for atrial fibrillation?

Results from a recent paper, almost half of participants who met our exclusion criteria were eligible for enrollment in a clinical trial. Younger participants with fewer prior CV events fared better in terms of adherence and clinical outcomes; older participants with more prior CV events fared better in terms of CV events.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Results from a recent clinical trial of the treatment of atrial fibrillation, no single treatment was consistently used in combination with any other treatment. However, atrial fibrillation can present as a complication with many different types of other treatments.

Anonymous Patient Answer
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