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Radiation Therapy
SABR for Cardiac Arrhythmias
Phase 1 & 2
Waitlist Available
Led By Joe Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG 0-2
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will test a new medical treatment for heart arrhythmias, to see if it is more effective and has less side effects than the current standard of care.
Who is the study for?
This trial is for adults over 18 with recurrent, rapid heartbeats due to structural heart disease who've had an ICD (implantable cardioverter-defibrillator) react at least twice in the last 3 months. They must have tried and failed one anti-arrhythmic medication and one catheter ablation procedure. It's not for those with a life expectancy under 12 months without VT, severe heart failure, recent revascularization, extremely low ejection fraction or excessive scar tissue.Check my eligibility
What is being tested?
The study tests Stereotactic Ablative Radiotherapy (SABR) against standard treatments like repeat catheter ablation or medication changes for stubborn cardiac arrhythmias. Phase I checks SABR safety on up to 15 patients before FDA review; if safe and effective, Phase II randomly assigns another 50 patients to either SABR or standard care.See study design
What are the potential side effects?
Potential side effects of SABR may include acute toxicity affecting organs near the treatment area within six months post-treatment. Standard treatments' side effects vary but can involve complications from further procedures or adverse reactions to medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I have a type of heart rhythm problem due to heart disease.
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My ICD stopped at least 2 fast heartbeats since my last VT treatment.
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I have tried at least one anti-arrhythmic drug without success for my VT.
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I've had at least one heart ablation procedure that didn't work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment2 Interventions
Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care)
Group II: Phase I:Experimental Treatment2 Interventions
Phase I there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,449 Total Patients Enrolled
1 Trials studying Arrhythmia
43 Patients Enrolled for Arrhythmia
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,996,587 Total Patients Enrolled
Joe ChangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have ventricular tachycardia with no known cause.Your heart is not pumping enough blood.I have a type of heart rhythm problem due to heart disease.My ICD stopped at least 2 fast heartbeats since my last VT treatment.My last invasive heart procedure was less than 2 weeks ago.I have had a procedure to improve blood flow within the last 30 days.I am able to care for myself and perform daily activities.I am 18 years old or older.Doctors think it's unlikely that you will live for at least 12 months without receiving the study treatment.I have a type of irregular heartbeat called polymorphic VT.My scar tissue is larger than 80cc and the treatment area is over 300cc.You have a left ventricular assist device.I am currently experiencing a worsening of my heart failure.I am currently pregnant.I have had radiation treatment to my chest before.I have an active illness or infection that is not related to heart problems.I have a heart condition that can cause irregular heartbeats.There is no data from your heart device in the last 3 months.I have had a heart transplant.Your heart shows signs of having more than one problem causing irregular heartbeats during testing.I need medication to help my heart pump better.I have experienced ventricular fibrillation.I have experienced a severe failure of my heart to pump blood.I have a fast heart rate that makes me feel unstable.I have tried at least one anti-arrhythmic drug without success for my VT.I've had at least one heart ablation procedure that didn't work.You can participate in the study no matter if you have had cancer before, but you need to be expected to live for at least 12 months without certain blood clot conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I:
- Group 2: Phase II
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.
Is there still an opportunity to join this medical experiment?
"This particular trial is no longer recruiting volunteers, as evidenced by clinicaltrials.gov's records which show that it was last amended on June 1st 2022. Despite this, there are still 186 trials searching for participants at the present moment."
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