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Gene Therapy

Gene Therapy for Atrial Fibrillation (AFGT01 Trial)

Phase 1

Recruiting

Led By Kevin Donahue, MD

Research Sponsored by Kevin Donahue

Eligibility Criteria Checklist

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

Must have

Elective valve surgery (alone or with coronary artery bypass grafting surgery) and one of the risk factors listed below, or elective coronary artery bypass grafting surgery with two of the risk factors listed below

Risk factors: age greater than 70, increased left atrial size (> 4 cm left atrial diameter or LA volume index > 35 on echocardiogram), obesity (body mass index > 30)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

AFGT01 Trial Summary

This trial will test how safe a new medical intervention is for cardiac surgery patients at risk of atrial fibrillation.

Who is the study for?

This trial is for adults over 70 with risk factors like a large left atrium, obesity, or history of heart issues. It's for those having valve surgery with one listed risk factor or bypass surgery with two. Excluded are people with persistent AF, significant bradyarrhythmias without pacemaker treatment, prior gene therapy, low LVEF, recent other trials participation, severe renal disease, and certain conditions affecting life expectancy.Check my eligibility

What is being tested?

The trial tests AdKCNH2-G628S gene therapy in patients at high risk of post-operative atrial fibrillation after cardiac surgery. It includes a dose-ranging study followed by random assignment to two doses compared against control patients undergoing standard cardiac procedures.See study design

What are the potential side effects?

While the specific side effects aren't detailed here, typical concerns in gene therapy may include immune reactions to the vector (like fever), potential for off-target genetic effects or inflammation at injection sites. The safety assessment will monitor these and other related risks.

AFGT01 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for heart valve or bypass surgery and meet the required risk factors.

Select...

I am over 70, have a large left atrium, or am obese.

AFGT01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

proportion of patients having a post-operative complication relative to controls

Secondary outcome measures

proportion of patients having post-operative atrial fibrillation

AFGT01 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: low doseExperimental Treatment1 Intervention

second phase, fixed dose 5x10(11) vp

Group II: high doseExperimental Treatment1 Intervention

second phase, fixed dose 2x10(12) vp

Group III: dose escalationExperimental Treatment1 Intervention

initial phase, increasing dose

Group IV: controlActive Control1 Intervention

second phase, blinded, randomized with no intervention delivered but with testing and monitoring.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kevin DonahueLead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,046 Total Patients Enrolled

45 Trials studying Atrial Fibrillation

539,515 Patients Enrolled for Atrial Fibrillation

University of Massachusetts, WorcesterLead Sponsor

343 Previous Clinical Trials

986,532 Total Patients Enrolled

7 Trials studying Atrial Fibrillation

38,863 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

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

Is there an ongoing opportunity to join this clinical research?

"Affirmative. Information available on clinicaltrials.gov reveals that this experiment, which was initially advertised on October 1st 2023, is actively recruiting participants. Nearly 78 individuals must be enrolled from a single facility."

Answered by AI

What safety precautions should be taken when administering high doses to individuals?

"Considering the limited amount of clinical data available, our team has rated high dose's safety a 1 on a scale from 1 to 3. This is due to its status as being in Phase 1 trials."

Answered by AI

How many people have been accepted to participate in the research project?

"Affirmative. Clinicaltrials.gov provides evidence that this research project, which was first announced on October 1st 2023, is currently open for recruitment. It seeks to enroll 78 individuals from a single clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gene Therapy for Post-Operative Atrial Fibrillation

Kevin Donahue 2023. "Gene Therapy for Post-Operative Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05223725.

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