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Tailored Catheter Ablation for Atrial Fibrillation (RESTART Trial)
N/A
Recruiting
Research Sponsored by Volta Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure
Patients 21 years of age or older indicated for redo AF ablation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
RESTART Trial Summary
This trial is studying if using a new algorithm in combination with a repeated ablation could help reduce recurrence of a heart condition.
Who is the study for?
This trial is for adults over 21 with recurrent Atrial Fibrillation (AF) after previous catheter or surgical ablation. Participants must have had symptomatic AF in the last year and been on anticoagulants like warfarin or NOACs for at least 4 weeks. Exclusions include severe heart failure, recent clots, major lung disease, very dilated Left Atrium, pregnancy, and certain other health conditions.Check my eligibility
What is being tested?
The study tests a tailored repeat catheter ablation approach using Volta's VX1 algorithm in patients whose AF returned after initial treatment. It's an international multi-center trial that isn't randomized; all participants receive the intervention to see how well it works.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of catheter ablation may include bleeding at the site where the catheter was inserted, damage to blood vessels or heart valves from the catheter, arrhythmias (irregular heartbeats), infection risk from invasive procedures.
RESTART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had symptoms of AF that lasted even 3 months after my last AF treatment.
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I am 21 or older and need a repeat procedure for atrial fibrillation.
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I have had a procedure to treat irregular heartbeats.
RESTART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from AF
RESTART Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Patients undergoing catheter ablation that qualify after initial screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Catheter Ablation
2009
Completed Phase 4
~3720
Find a Location
Who is running the clinical trial?
Volta MedicalLead Sponsor
4 Previous Clinical Trials
967 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
967 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of abnormal blood clotting or bleeding.I currently have an acute Covid-19 infection with fever or inflammation.I have been on blood thinners like warfarin or NOAC for more than 4 weeks.I have severe lung disease or chronic respiratory symptoms.I have had complications from a previous ablation procedure.I have had symptoms of AF that lasted even 3 months after my last AF treatment.My atrial fibrillation is due to a treatable cause.My atrial fibrillation has come back before the study's redo procedure.My BMI is over 50, indicating severe obesity.I have been diagnosed with atrial myxoma.My heart's left atrium is very enlarged.I am scheduled for a heart transplant or surgery within the next year.I have not had any heart surgery, including stent placement, in the last 2 months.I have a blood clot in my heart as seen on a special heart scan.My first AF ablation was for persistent AF lasting over 24 months.You are not taking enough medication to prevent blood clots, as stated in the rules for who can join the study.My heart function is severely impaired.I have had AF ablation with VX1 software before.I do not have any current infections or severe illnesses.You are not expected to live more than 12 months due to other health issues.You are currently taking part in a study testing a different medication or treatment.My atrial fibrillation is due to an imbalance in body salts, thyroid issues, or a non-heart related cause.I have had severe chest pain within the last month.I have had surgery on my heart's atrioventricular valve.I cannot take blood thinners like heparin, warfarin, or NOACs.I have had a stroke or similar event in the last year.I have been diagnosed with thickened heart muscles.I have been diagnosed with cardiac sarcoidosis.I have been diagnosed with rheumatic heart disease.I have not had a heart attack in the last 2 months.I cannot have a catheter due to a blockage or condition in my blood vessels.I am 21 or older and need a repeat procedure for atrial fibrillation.I have had a procedure to treat irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have signed up to take part in this medical experiment?
"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was inaugurated on March 17th 2023, is currently open for recruitment of 92 subjects at 1 medical centre."
Answered by AI
Can those in need participate in this exploration?
"The trial, initially advertised on March 17th 2023 and modified most recently on May 1st 2023 is actively seeking participants."
Answered by AI
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