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Catheter vs Radio-Ablation for Ventricular Tachycardia (CARA-VT RCT Trial)
Phase 3
Recruiting
Led By Calum Redpath
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND Recurrent VT events despite previous CA
Patient aged ≥55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
CARA-VT RCT Trial Summary
This trialcompares an invasive procedure to non-invasive radio ablation to treat ventricular tachycardia, using a novel mapping tech.
Who is the study for?
This trial is for patients aged 55 or older with a type of heart disease called cardiomyopathy, poor heart function (ejection fraction ≤ 35%), and an implanted defibrillator. They must have experienced repeated rapid heartbeats despite previous treatments. Excluded are those unable to consent, women who may become pregnant not using effective birth control, severe heart failure patients, those with less than a year to live, prior chest radiotherapy recipients, participants in other trials, and anyone under 55.Check my eligibility
What is being tested?
The study compares two treatments for rapid heartbeat due to ventricular tachycardia: the standard invasive procedure using catheters versus a new non-invasive method using targeted radio waves guided by advanced ECG mapping technology. Patients will be randomly assigned to one of these treatment groups.See study design
What are the potential side effects?
Potential side effects from catheter ablation can include bleeding or infection at the insertion site and damage to the blood vessels or heart. Radio ablation might cause skin irritation where the rays enter the body and could potentially affect nearby organs.
CARA-VT RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a weak heart (LVEF ≤ 35%) with an ICD and still experience frequent VT despite past ablation.
Select...
I am 55 years old or older.
Select...
My heart's pumping ability is weak, I have a device implanted for it, and I've had serious heart rhythm problems.
CARA-VT RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to composite event
Secondary outcome measures
Any ICD shock at any time or after 14 days
Any ventricular arrhythmia event at any time or after 14 days
Appropriate ICD ATP at any time or after 14 days
+15 moreCARA-VT RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Radio-ablation using non-invasive mapping
Group II: ControlActive Control1 Intervention
Catheter Ablation using invasive mapping
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,192 Total Patients Enrolled
Calum RedpathPrincipal InvestigatorOttawa Heart Institute Research Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently breastfeeding.Women who could become pregnant must have a negative pregnancy test before joining the study.I am 54 years old or younger.I cannot or do not want to give permission for treatment.I have a weak heart (LVEF ≤ 35%) with an ICD and still experience frequent VT despite past ablation.I have severe heart failure or have a heart pump.You are not expected to live for more than one year for any reason.I have had radiation therapy to my chest area before.You are currently participating in another research study where your treatment is randomly assigned.I am 55 years old or older.My heart's pumping ability is weak, I have a device implanted for it, and I've had serious heart rhythm problems.I am a woman of childbearing age and I refuse to use effective birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 deleterious is the application of this treatment to patients?
"Power's evaluation of the safety profile for this therapy is a 3, due to evidence from both efficacy studies and multiple iterations of data collection."
Answered by AI
What is the total number of participants in this clinical trial?
"Affirmative. The information provided on clinicaltrials.gov reveals that recruitment for this trial is ongoing, with the initial post published on December 6th 2022 and a subsequent update occurring exactly one day later. This study requires 244 volunteers from a single medical centre to participate."
Answered by AI
Are participants still being recruited for this investigation?
"Correct. According to the records hosted on clinicaltrials.gov, this medical trial - which was first published on December 6th 2022 - is currently open for recruitment and requires 244 participants from a single site. The study has been recently updated as of December 7th 2022."
Answered by AI
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