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Antiarrhythmic
Radiofrequency Ablation vs Antiarrhythmic Drugs for Atrial Fibrillation (RAAFT-3 Trial)
Phase 3
Waitlist Available
Led By Andrea Natale, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients symptomatic with persistent AF
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
RAAFT-3 Trial Summary
This trial will compare the two treatments to see which is better for people with a certain heart condition.
Who is the study for?
This trial is for adults over 18 with persistent atrial fibrillation (AF), which means their heart has been in an irregular rhythm for more than 7 days. They must have had at least two AF episodes in the past 9 months, documented by ECG. People can't join if they have severe heart issues, previous AF treatments, are pregnant, or have conditions that could interfere with the study.Check my eligibility
What is being tested?
The RAAFT-3 trial is testing whether using a procedure called Radio Frequency Catheter Ablation to isolate pulmonary veins works better as a first treatment for persistent AF compared to standard antiarrhythmic drugs.See study design
What are the potential side effects?
Possible side effects from ablation include bleeding or bruising at the catheter site, damage to blood vessels or heart tissue, and risks associated with anesthesia. Antiarrhythmic drugs may cause nausea, dizziness, fatigue or more serious effects like organ dysfunction.
RAAFT-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have ongoing symptoms from atrial fibrillation.
RAAFT-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence of symptomatic Atrial Fibrillation
Secondary outcome measures
AF/AT Burden
CV Hospitalizations
Quality of Life Questionnaire
+2 moreRAAFT-3 Trial Design
2Treatment groups
Active Control
Group I: Antiarrhythmic MedicationsActive Control1 Intervention
Patients randomized to the antiarrhythmic drug group are administered medications approved for treatment of AF by the regulatory bodies of each participating country. The selection of antiarrhythmic drugs and dosages is left to the discretion of the investigator, and will follow the AHA/ACC/HRS general guidelines
Group II: Radio Frequency Catheter AblationActive Control1 Intervention
Patients randomized to radiofrequency catheter ablation will undergo isolation of the pulmonary veins with confirmation of entrance block into each vein. The CARTO TM(Biosense Webster, CA) system will be used to reconstruct the atrial geometry and assist for mapping and ablation. Ablation will be performed using approved ablation devices (Biosense Webster, CA).
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,940 Total Patients Enrolled
16 Trials studying Atrial Fibrillation
2,711 Patients Enrolled for Atrial Fibrillation
Texas Cardiac Arrhythmia Research FoundationOTHER
37 Previous Clinical Trials
13,260 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
6,525 Patients Enrolled for Atrial Fibrillation
Biosense Webster, Inc.Industry Sponsor
122 Previous Clinical Trials
36,467 Total Patients Enrolled
81 Trials studying Atrial Fibrillation
28,384 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that makes it unlikely for you to live another year.I am currently pregnant.I have had a procedure to treat irregular heartbeat.I am older than 18 years.I have had at least 2 episodes of atrial fibrillation in the last 9 months.You have had at least one episode of atrial fibrillation (AF) confirmed by a heart test in the 6 months before the study starts.I cannot use heparin or blood thinners.My thyroid condition is managed and under control with medication.I currently have a heart infection or a systemic infection.I have taken medication for irregular heartbeat before.I have had at least 2 episodes of AF lasting more than 7 days each in the last 9 months.I have severe heart artery blockage or had a recent heart bypass surgery.I do not have severe lung problems like COPD.I have a serious heart valve problem.I cannot have a catheter ablation due to a clot or abnormality in my heart's left atrium.I have a high risk of bleeding or a history of severe bleeding problems.I am over 18, have persistent AF symptoms, and had an AF episode documented by ECG in the last 6 months.Your heart's pumping function is less than 40%.Your heart's left atrium is documented to be 6 centimeters or larger.You have moderate to severe thickening of the left ventricle of your heart.I have ongoing symptoms from atrial fibrillation.I cannot take any antiarrhythmic drugs like sotalol or amiodarone.
Research Study Groups:
This trial has the following groups:- Group 1: Antiarrhythmic Medications
- Group 2: Radio Frequency Catheter Ablation
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT04037397 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there several sites running this study in different states?
"Presently, this research is being conducted at 7 different locations, which include Austin, Cleveland and Philadelphia. If you are interested in participating, you should aim to be located near one of these sites to reduce travel-related burdens."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
What site did they apply to?
MetroHealth
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
What is inclusion criteria?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I have had previous ablations and still getting break through AFB, on medication to keep in rhythm with moderate success, other medications were deemed contraindicated.
PatientReceived 1 prior treatment
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