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Radiofrequency Ablation

Radiofrequency Ablation for Atrial Fibrillation (Diamond-AFII Trial)

N/A

Waitlist Available

Led By Atul Verma, 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

Must not have

Continuous AF >12 months (long-standing persistent AF)

Rheumatic heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

Awards & highlights

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.

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.

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.

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 over 18 years old or of legal age to consent where I live.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had atrial fibrillation for more than a year.

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I have rheumatic heart disease.

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My longest episode of irregular heartbeat lasted less than 7 days.

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I have severe heart issues or uncontrolled heart failure.

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I have had a procedure on my heart's left atrium, septum, or mitral valve.

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I have severe leakage in my heart's mitral valve.

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I have a bleeding or clotting disorder.

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I have a serious lung condition that affects my breathing.

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I am allergic or intolerant to blood thinners or contrast agents used in the study.

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I have not had a major GI bleed in the last 3 months.

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I have not had a heart bypass surgery in the last 6 months.

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My kidney function is low, with high creatinine or low clearance.

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I have been diagnosed with thickened heart muscles.

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I have a condition that makes it difficult to insert or manipulate a catheter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

This trial's timeline: 3 weeks for screening, Varies for treatment, and between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Ability to perform first-pass PV antral isolation

Atrial Fibrillation

Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation

+16 more

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

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor

201 Previous Clinical Trials

129,710 Total Patients Enrolled

44 Trials studying Atrial Fibrillation

21,944 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

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

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

~5 spots leftby Oct 2024

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