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Radiofrequency Ablation

Radiofrequency Ablation for Atrial Fibrillation (Diamond-AFII Trial)

N/A
Waitlist Available
Led By Andrea Natale, MD
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with a history of documented symptomatic, persistent atrial fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months and 2) a 24-hour Holter within 90 days of the ablation procedure showing continuous AF
Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 6 months and 12 months after the index ablation procedure
Awards & highlights

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.

Who is the study for?
This trial is for adults with persistent atrial fibrillation who haven't responded to certain anti-arrhythmic drugs. Participants must have had continuous AF for more than 7 days but less than a year, be suitable for heart mapping and ablation, and commit to follow-up visits for a year. Exclusions include long-standing AF over 12 months, severe heart or lung conditions, recent major cardiac events or procedures, stroke history within six months, extreme obesity (BMI >42), or life expectancy under one year.Check my eligibility
What is being tested?
The DiamondTemp Ablation System is being tested in this study. It's designed to treat patients with persistent atrial fibrillation that doesn't respond well to medication. The system uses radiofrequency energy to destroy small areas of heart tissue responsible for the irregular heartbeat.See study design
What are the potential side effects?
While not specified here, side effects of radiofrequency ablation can include discomfort at the site of ablation, bleeding or infection where catheters were inserted; rare risks involve damage to the heart or blood vessels, stroke-like symptoms due to clots or air bubbles.

Diamond-AFII Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a long-lasting episode of atrial fibrillation documented by a doctor and confirmed with a recent test.
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I cannot take certain heart rhythm medications due to side effects or other reasons.
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I am a good candidate for a procedure to treat irregular heartbeats.
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I am over 18 years old or of legal age to consent where I live.

Diamond-AFII Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 6 months and 12 months after the index ablation procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 6 months and 12 months after the index ablation procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of device or procedure related Serious Adverse Events measured at 7 days in all subjects
Incidence of device or procedure related clinically significant tamponade/perforation measured at 30 days in all subjects.
Atrial Fibrillation
+1 more
Secondary outcome measures
Ability to perform first-pass PV antral isolation
Atrial Fibrillation
Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation
+16 more

Diamond-AFII Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Ablation
2013
Completed Phase 4
~740

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
198 Previous Clinical Trials
131,906 Total Patients Enrolled
42 Trials studying Atrial Fibrillation
24,891 Patients Enrolled for Atrial Fibrillation
Andrea Natale, MDPrincipal InvestigatorDirector, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center
35 Previous Clinical Trials
7,842 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
7,063 Patients Enrolled for Atrial Fibrillation
Atul Verma, MDPrincipal InvestigatorMedical Director, Heart Rhythm Program, Southlake Regional Health Centre
12 Previous Clinical Trials
2,716 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
2,691 Patients Enrolled for Atrial Fibrillation

Media Library

DiamondTemp™ System (Radiofrequency Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT03643224 — N/A
Atrial Fibrillation Research Study Groups: Experimental
Atrial Fibrillation Clinical Trial 2023: DiamondTemp™ System Highlights & Side Effects. Trial Name: NCT03643224 — N/A
DiamondTemp™ System (Radiofrequency Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03643224 — N/A

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~40 spots leftby Dec 2024