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Procedure

Catheter Ablation for Atrial Fibrillation

Q: Are recruitment efforts still underway for this experiment?

Affirmative. The clinicaltrials.gov page indicates that the trial, first created on February 19th 2021, is actively recruiting subjects and aims to enrol 200 individuals from a single site.

Q: Does the trial have an age restriction, and if so, what is it?

This clinical trial is restricted to adults aged 18-100. There are 11 studies relating to minors and 474 for those above the age of seniority.

Q: How numerous are the participants in this experiment?

Affirmative. Information on clinicaltrials.gov asserts that this research study is open for recruitment, which was first initiated on February 19th 2021 and last revised on September 13th 2022. The investigation requires 200 volunteers from 1 medical centre to join the trial.

Q: How can I join this experiment?

This medical trial is searching for 200 people aged between 18 and 100 with a diagnosis of <a href="https://www.withpower.com/clinical-trials/atrial-fibrillation">atrial fibrillation</a>. As well as matching this age range, applicants must be adults who are undergoing the first catheter ablation guided by cardiac CT imaging.

N/A

Recruiting

Led By Hiroshi Ashikaga, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 to 100 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is investigating the clinical significance of peri-atrial inflammatory fat tissue in atrial fibrillation using ultra-high resolution CT.

Who is the study for?

This trial is for adults aged 18 to 100 who are undergoing their first catheter ablation for atrial fibrillation and need a cardiac CT scan. It's not suitable for those unable to consent, with severe kidney issues (eGFR <30), or with a known severe allergy to contrast dye used in scans.Check my eligibility

What is being tested?

The study is testing the significance of peri-atrial inflammatory fat tissue in atrial fibrillation by using high-resolution CT scans. The goal is to see if this fat tissue can predict recurrence after the ablation procedure.See study design

What are the potential side effects?

Potential side effects may include reactions related to the catheter ablation like bleeding or infection at the insertion site, heart damage, and risks associated with CT scans such as exposure to radiation and allergic reactions to contrast dye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 100 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from any documented episode of AF

Secondary outcome measures

Freedom from any documented atrial arrhythmia after one ablation procedure

Freedom from any documented atrial arrhythmia after two ablation procedures

Freedom from documented AF after two ablation procedures

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: Persistent AF - PVI + Fat-targeted ablationExperimental Treatment1 Intervention

The subjects with persistent AF undergo pulmonary vein isolation (PVI) and additional ablation to target the inflammatory fat tissue

Group II: Arm 2: Persistent AF - PVI armPlacebo Group1 Intervention

The subjects with persistent AF undergo pulmonary vein isolation (PVI).

Group III: Arm 1: Paroxysmal AF - PVI armPlacebo Group1 Intervention

The subjects with paroxysmal AF undergo pulmonary vein isolation (PVI).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Catheter ablation

2016

Completed Phase 4

~810

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,259 Previous Clinical Trials

14,820,453 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

7,449 Patients Enrolled for Atrial Fibrillation

Hiroshi Ashikaga, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Catheter ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04186169 — N/A

Atrial Fibrillation Research Study Groups: Arm 2: Persistent AF - PVI arm, Arm 3: Persistent AF - PVI + Fat-targeted ablation, Arm 1: Paroxysmal AF - PVI arm

Atrial Fibrillation Clinical Trial 2023: Catheter ablation Highlights & Side Effects. Trial Name: NCT04186169 — N/A

Catheter ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186169 — N/A

Frequently Asked Questions

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

Are recruitment efforts still underway for this experiment?

"Affirmative. The clinicaltrials.gov page indicates that the trial, first created on February 19th 2021, is actively recruiting subjects and aims to enrol 200 individuals from a single site."

Answered by AI

Does the trial have an age restriction, and if so, what is it?

"This clinical trial is restricted to adults aged 18-100. There are 11 studies relating to minors and 474 for those above the age of seniority."

Answered by AI

How numerous are the participants in this experiment?

"Affirmative. Information on clinicaltrials.gov asserts that this research study is open for recruitment, which was first initiated on February 19th 2021 and last revised on September 13th 2022. The investigation requires 200 volunteers from 1 medical centre to join the trial."

Answered by AI

How can I join this experiment?

"This medical trial is searching for 200 people aged between 18 and 100 with a diagnosis of atrial fibrillation. As well as matching this age range, applicants must be adults who are undergoing the first catheter ablation guided by cardiac CT imaging."

Answered by AI