Treatment for Atrial Fibrillation

Phase-Based Estimates
1
Effectiveness
1
Safety
Iowa Heart Center, West Des Moines, IA
Atrial Fibrillation
Eligibility
18+
All Sexes
Eligible conditions
Atrial Fibrillation

Study Summary

This study is evaluating whether a different type of ablation may be more effective than the current standard for treating atrial fibrillation.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Atrial Fibrillation. Measurement will happen over the course of Six months.

Six months
PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 50 total participants across 1 different treatment groups

This trial involves a single treatment. 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.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: six months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly six months for reporting.

Closest Location

Iowa Heart Center - West Des Moines, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Atrial Fibrillation. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice;
Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling institution more than 3 month or more prior to the anticipated repeat ablation;
Age ≥ 18 years.

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 are the signs of atrial fibrillation?

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Although the symptoms of atrial fibrillation can be nonspecific and may resemble other conditions, some of the key signs are highly specific and should lead to the diagnosis in all patients with AF. Signs that may lead to a diagnosis of AF include a wide-based jugular venous pulse, low-voltage P wave on electrocardiogram (ECG), and a positive drape sign on supine radiographs of the chest and left side of the pelvis.

Unverified Answer

What causes atrial fibrillation?

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While AF can occur in anyone, the most important risk factor for incident AF in healthy middle-aged women is early occurrence of ischemic stroke or transient ischemic attack.

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What are common treatments for atrial fibrillation?

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Almost one-third had had previous catheter ablation, with catheter ablation being the most common modality. About 1/5 had previously undergone revascularization procedures to treat atrial or ventricular hypertrophy or other heart disorders; of these 9 had undergone PVI as well. While the vast majority of AF patients were treated with anti-arrhythmics, a significant proportion received anticoagulants. The use of PVI for AF in patients with a CHADS2 score of 2 is common, though use of anticoagulants and antiarrhythmic drugs may be greater among those patients with a previous history of atrial fibrillation or heart disease.

Unverified Answer

What is atrial fibrillation?

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The atrial fibrillation is a common heart rhythm disturbance, with an incidence of approximately 1 per 1,000 population and 20% of patients with heart rhythm disturbances. We need to consider more precisely the clinical evaluation of patients with atrial fibrillation and provide optimal therapeutic options.

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Can atrial fibrillation be cured?

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In our experience, the chances of successful anticoagulation are not higher than other forms of AF; this is especially true if the underlying underlying disease is not related with AF. Results from a recent clinical trial show that anticoagulation alone is a simple and effective strategy in treating patients with persistent AF on drug therapy for primary or secondary AF.

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

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Over two percent of all adults in the US get atrial fibrillation each year. The incidence of atrial fibrillation increases with age and is greatest in those older than 80 years.

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What are the common side effects of treatment?

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The reported side effects of amiodarone can be categorised into acute effects, which appear during the first few days of treatment, and long-term effects, which appear after 1 week of treatment. The common side effects of amiodarone are diarrhoea, fatigue, nausea and vertigo. Rare side effects are serious allergic reactions and severe swelling around the throat.

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How does treatment work?

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It has been hypothesized that the treatment of atrial fibrillation is based exclusively on symptomatological effects but recent data indicate that it is possible to alter the heart rhythm permanently. Atrial fibrillation should be considered as a disease with multiple subtypes with different pharmacological and therapeutic treatments possible.

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What is the primary cause of atrial fibrillation?

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In the majority of cases, AF is idiopathic, that is, there are no known triggers for AF. Idiopathic AF accounts for 75% to 90% of all cases of AF. AF is often associated with left atrial enlargement and hypertrophy.

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Does treatment improve quality of life for those with atrial fibrillation?

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While HRQoL, as measured by the SF-36, is improved in patients treated with warfarin, in patients treated with oral anticoagulants or aspirin this effect is not statistically significant.

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Have there been other clinical trials involving treatment?

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Almost one-third of the patients with atrial fibrillation had no other clinical or laboratory evidence of cardiovascular disease. Almost one-third of them had at least one risk factor associated with a cardiovascular disease. The treatment-eligibility was less favourable for patients with one or more risk factors compared with those who were free of risk. Nevertheless, one-third of all the patients with atrial fibrillation could have been eligible for atrial fibrillation treatment if a treatment had been offered. This should be given special consideration when deciding whether to offer treatment.

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Have there been any new discoveries for treating atrial fibrillation?

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Drugs already in the clinic are getting more validation with regard to the treatment of atrial fibrillation and are starting to show greater benefits. Further research and clinical trials are being conducted to better understand its mechanism of action.

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