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Ablation Therapy
Ablation Therapy for Ventricular Tachycardia (LESS-VT Trial)
N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Refractory to at least one anti-arrhythmic medication for treatment of MMVT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
LESS-VT Trial Summary
This trial is testing a new ablation therapy for people with a certain type of heart arrhythmia that keeps coming back or can't be treated with drugs.
Who is the study for?
This trial is for adults over 18 with a rapid heartbeat condition called monomorphic ventricular tachycardia that hasn't improved with drugs, or if they can't tolerate the medication. They must have an ICD or CRT-D implant and be struggling with this despite anti-arrhythmic meds. People with certain heart diseases confirmed by tests are eligible, but not those who've had recent heart attacks, strokes, severe valve issues, very low ejection fraction, blood disorders, uncontrolled infections or other serious health problems.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a procedure using the FlexAbility Sensor Enabled Ablation Catheter to treat patients whose rapid heartbeat (ventricular tachycardia) doesn't get better with medication. The goal is to see if this catheter can safely correct their heart rhythm when drugs fail.See study design
What are the potential side effects?
Potential side effects from ablation therapy include discomfort at the site where catheters are inserted, bleeding or bruising there too; risks associated with anesthesia; possible damage to blood vessels or heart tissue during the procedure which could lead to more arrhythmias; and in rare cases stroke or heart attack.
LESS-VT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My heart condition didn't improve with at least one medication.
LESS-VT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from recurrence of VT
Rate of complications
LESS-VT Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Non-randomized - TreatmentExperimental Treatment1 Intervention
Subjects with NICM will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure.
Group II: Randomized - ControlActive Control1 Intervention
Subjects with ICM and randomized to the Control group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with any of the protocol-specified commercially available ablation catheters indicated for patients with ICM. A protocol-specified commercially available mapping system will be used in conjunction with the control catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure.
Group III: Randomized - TreatmentActive Control1 Intervention
Subjects with ICM and randomized to the Treatment group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,596 Total Patients Enrolled
Kristin Ruffner, PhDStudy DirectorAbbott
9 Previous Clinical Trials
10,398 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a severe heart attack within the last 60 days.I cannot take blood thinners due to health reasons.I had heart surgery less than 60 days before my planned ablation.My VT can potentially be treated or reversed.I have a severe narrowing of my aortic valve or a severely damaged mitral valve.I have had a stroke and now need help with my daily activities.I have unstable chest pain.I have severe, ongoing heart failure.I am not pregnant or nursing.I had a procedure to open my heart's arteries within the last 30 days.I am 18 years old or older.I have a type of irregular heartbeat not caused by known conditions.My heart condition didn't improve with at least one medication.My irregular heartbeats are due to a genetic heart condition.I currently have an infection that isn't under control.I have a heart condition confirmed by tests or my heart pumps less effectively.I have a low platelet count or a blood clotting disorder.I need urgent treatment for my irregular heartbeats before a specific heart procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized - Control
- Group 2: Randomized - Treatment
- Group 3: Non-randomized - Treatment
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 is the research team looking to recruit for this clinical trial?
"Affirmative. The clinicaltrials.gov website reports that this experimental research, first published on June 1st 2018, is presently recruiting participants. A total of 592 individuals need to be recruited across 16 different medical facilities."
Answered by AI
How many locations are hosting this research project?
"Currently, patients can enrol in this trial from 16 different medical sites located across the United States. The main hubs are Charleston, Baltimore and Minneapolis; however there are other facilities available as well to reduce travel-related burdens for participants."
Answered by AI
Is enrollment in this experiment currently being accepted?
"Yes, as per the information on clinicaltrials.gov, this medical trial is still recruiting participants. The study was first posted on June 1st 2018 and its most recent update took place on December 5th 2022. The research requires a total of 592 patients to be enrolled from 16 different sites."
Answered by AI
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