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Radiofrequency Ablation for Atrial Fibrillation (Diamond-AFII Trial)
Diamond-AFII Trial Summary
This trial is testing a new ablation system to see if it is safe and effective for treating patients with atrial fibrillation that does not respond to medication.
Diamond-AFII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDiamond-AFII Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Diamond-AFII Trial Design
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Who is running the clinical trial?
Media Library
- I have had atrial fibrillation for more than a year.My atrial fibrillation is due to an imbalance in body salts, thyroid issues, or a non-heart related cause.I have rheumatic heart disease.I had a device like a pacemaker or ICD implanted within the last 6 months.Women who could become pregnant or are breastfeeding and have a positive pregnancy test cannot participate.My longest episode of irregular heartbeat lasted less than 7 days.Your left atrium is larger than 5.5 centimeters.I have severe heart issues or uncontrolled heart failure.You have a very high body mass index (BMI).I have had a procedure on my heart's left atrium, septum, or mitral valve.You have a blood clot in the large arteries that has been confirmed by imaging within the past month or just before the procedure.I have severe leakage in my heart's mitral valve.I have a bleeding or clotting disorder.I have a serious lung condition that affects my breathing.I do not require dialysis and my kidney function is stable enough to participate in a study.I am allergic or intolerant to blood thinners or contrast agents used in the study.I have not had a heart attack, unstable angina, heart surgery, or coronary intervention in the last 3 months.I have had a long-lasting episode of atrial fibrillation documented by a doctor and confirmed with a recent test.I cannot take certain heart rhythm medications due to side effects or other reasons.I have not had a major GI bleed in the last 3 months.I have not had a heart bypass surgery in the last 6 months.You are not expected to live for more than 12 months based on your medical history or your doctor's opinion.My kidney function is low, with high creatinine or low clearance.I am a good candidate for a procedure to treat irregular heartbeats.I have not had a fever or serious infection in the last week.I have been diagnosed with thickened heart muscles.Your heart's pumping ability is less than 40%.I have had a stroke or similar event in the last 6 months.I have a condition that makes it difficult to insert or manipulate a catheter.I am over 18 years old or of legal age to consent where I live.
- Group 1: Experimental
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the total enrollment capacity of this clinical trial?
"This medical trial requires 376 eligible patients and offers potential participants the chance to join from multiple locations, including Keck School Of Medicine in Los Angeles, California and Iowa Heart Center in West Des Moines, Iowa."
Is there an open call for participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this research study is presently recruiting suitable candidates; it was initially posted on September 20th 2018 and most recently updated on October 25th 2022. This trial requires 376 participants from 8 different medical centres across the country."
What are the principal aims of this trial?
"According to the clinical trial sponsor, Medtronic Cardiac Rhythm and Heart failure, the primary evaluation metric of this study is calculating incidence of symptomatic pulmonary vein stenosis and atrioesophageal fistula over a 3-12 month period. Additionally, secondary outcomes such as single procedure success rate (defined by freedom from documented AF, AT and AFL at 12 months), total fluoroscopy time (minutes) ,and acute procedural success rate (defined by confirmation of electrical isolation of PVs via assessment 20 mins after last ablation around respective PV ) will be tracked throughout the duration of this experiment."
How widely distributed are the locations of the medical facilities conducting this experiment?
"At the moment, 8 sites across four cities are recruiting participants for this study. These include Los Angeles, West Des Moines, and Tupelo alongside other neighbouring locations. To reduce travel-related expenses, it is recommended to join at the closest possible site."
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