Catheter vs Radio-Ablation for Ventricular Tachycardia

(CARA-VT RCT Trial)

Overseen By Calum Redpath

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: NYHA Class IV, LVAD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

244 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for ventricular tachycardia?

Research suggests that non-invasive stereotactic radioablation, a treatment originally used for solid tumors, shows promise in treating ventricular tachycardia (VT) by effectively targeting areas that are hard to reach with traditional catheter ablation. Initial clinical results indicate good short-term success in reducing VT episodes with manageable side effects. ^{1 2 3 4 5}

Is the treatment of ventricular tachycardia with catheter ablation or radio ablation generally safe for humans?

Studies suggest that catheter ablation for ventricular tachycardia is generally safe, with safety data available from clinical practice. Radio ablation, while newer, has shown limited toxicities in early trials, but its full safety profile is not yet completely understood. ^{1 2 6 7 8}

How does the treatment for ventricular tachycardia differ from other treatments?

The non-invasive radio ablation treatment for ventricular tachycardia (VT) is unique because it uses stereotactic body radiation therapy, which allows it to target and treat areas of the heart that are difficult to reach with traditional catheter ablation. This method is non-invasive, meaning it doesn't require surgery or insertion of instruments into the body, and it can deliver precise energy to specific heart areas, potentially reducing recurrence rates compared to catheter ablation. ^{1 2 3 4 9}

What is the purpose of this trial?

This study compares two arms - the current standard of care catheter ablation for Ventricular Tachycardia compared to stereotactic radiotherapy to non-invasively ablate ventricular tachycardia using a novel non-invasive ECG based body surface mapping technology. This allows investigators to identify ventricular tachycardia circuits to target for subsequent radio ablation. To summarize, the current standard of care invasive catheter ablation to the non-invasive radio ablation.

Research Team

Calum Redpath

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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.

Inclusion Criteria

I have a weak heart (LVEF ≤ 35%) with an ICD and still experience frequent VT despite past ablation.

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.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedural Imaging and Stabilization

Medical stabilization and multimodal imaging are performed to identify VT circuits and stratify risk of intervention.

2-3 weeks

Multiple visits for imaging and evaluation

Treatment

Participants undergo either catheter ablation or radio-ablation for ventricular tachycardia.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of VT recurrence and ICD shocks.

6 months

Regular follow-up visits

Long-term Follow-up

Long-term outcomes and safety data are collected, including quality of life assessments and cardiac function monitoring.

3 years

Treatment Details

Interventions

• Control - Catheter Ablation for VT
• Treatment - Non-Invasive Radio Ablation for VT

Trial Overview 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.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Radio-ablation using non-invasive mapping

Group II: Control Active Control 1 Intervention

Catheter Ablation using invasive mapping

Control - Catheter Ablation for VT is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Catheter Ablation for VT for:

• Ventricular Tachycardia
• Recurrent VT
• VT in Structural Heart Disease

Approved in European Union as Catheter Ablation for VT for:

• Ventricular Tachycardia
• Recurrent VT
• VT in Ischemic Cardiomyopathy

Approved in Canada as Catheter Ablation for VT for:

• Ventricular Tachycardia
• Recurrent VT
• VT in Non-Ischemic Cardiomyopathy

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Findings from Research

In a prospective trial involving 19 patients with treatment-refractory ventricular tachycardia (VT) or PVC-related cardiomyopathy, noninvasive cardiac radioablation significantly reduced the median number of VT episodes from 119 to just 3, demonstrating high efficacy in managing arrhythmias.

The procedure had a modest safety profile, with only 10.5% of patients experiencing serious treatment-related adverse events, and it led to a significant decrease in the use of antiarrhythmic medications from 59% to 12%, along with improvements in quality of life for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Robinson, CG., Samson, PP., Moore, KMS., et al.[2020]

In a study involving seven patients with recurrent refractory ventricular tachycardia (VT), non-invasive cardiac stereotactic ablative radiotherapy (SABR) successfully suppressed VT in all patients, demonstrating its potential as a novel treatment option for those at high risk for traditional therapies.

For five patients followed for at least six months, there was an impressive 85% reduction in VT burden, and importantly, no high-grade side effects from the radiotherapy were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac stereotactic ablative radiotherapy for control of refractory ventricular tachycardia: initial UK multicentre experience. Lee, J., Bates, M., Shepherd, E., et al.[2022]

Catheter ablation is an effective treatment for ventricular tachycardia (VT), particularly using the antegrade transseptal approach with a high-resolution basket catheter.

High-resolution mapping can rapidly produce detailed voltage and activation maps, aiding in the identification of critical VT substrates, even in patients with extensive scar tissue and unstable VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of hemodynamically unstable ventricular tachycardia in ischemic cardiomyopathy using high-resolution mapping. Kaiser, L., Jularic, M., Akbulak, RÖ., et al.[2020]

Stereotactic body radioablation (SBRT) is a promising non-invasive treatment for ventricular tachycardia (VT), which is often difficult to treat with traditional catheter ablation due to high recurrence rates.

SBRT allows for targeted delivery of ablative energy to specific areas of the heart that are hard to reach with catheter techniques, potentially improving treatment outcomes for patients with VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Stereotactic Radioablation: A New Option for the Treatment of Ventricular Arrhythmias. Wei, C., Qian, P., Tedrow, U., et al.[2020]

Non-invasive stereotactic radioablation shows promising short-term efficacy in suppressing ventricular tachycardia (VT) in patients who cannot undergo catheter-based ablation or have had unsuccessful procedures.

The treatment has tolerable side effects, making it a potentially safer alternative for managing VT, as discussed in the review of current clinical evidence and expert consensus on treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radioablation for ventricular tachycardia. Hohmann, S., Hillmann, HAK., Müller-Leisse, J., et al.[2022]

The RAVENTA trial is a multi-center study designed to evaluate the safety and feasibility of high-dose stereotactic radiosurgery for treating refractory ventricular tachycardia, with a target sample size of 20 patients.

The primary goal is to ensure successful delivery of the treatment without severe side effects within the first 30 days, while also assessing the reduction in VT burden and quality of life over the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA). Blanck, O., Buergy, D., Vens, M., et al.[2021]

In a prospective trial involving 11 patients with recurrent ventricular tachycardia (VT), stereotactic arrhythmia radioablation (STAR) demonstrated a safety profile with only one patient experiencing a significant treatment-related adverse event, indicating it is a relatively safe option for this condition.

STAR resulted in an 84.3% reduction in VT burden among evaluable patients, suggesting it is an effective treatment for selected patients with VT, although many experienced recurrence and further interventions were needed, highlighting the need for long-term outcome studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. Miszczyk, M., Sajdok, M., Bednarek, J., et al.[2023]

In a study of 9699 hospitalizations for ventricular tachycardia (VT) ablation, adverse events (AEs) occurred in 8.5% of cases, with major AEs in 3.0% and a mortality rate of 1.1%, indicating that while VT ablation is generally safe, there are significant risks involved.

The study found that higher hospital procedural volumes (more than 25 cases per year) were associated with lower rates of AEs, suggesting that choosing experienced centers for VT ablation may enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. Katz, DF., Turakhia, MP., Sauer, WH., et al.[2023]

In a study involving 20 domestic swine, noninvasive cardiac ablation using proton beam radiation showed dose-dependent adverse effects on left ventricular (LV) function, with significant declines in ejection fraction and increases in LV volume observed about 3 months post-treatment.

The study found that higher radiation doses correlated with greater declines in LV function, emphasizing the importance of precise targeting and energy delivery in noninvasive ablation procedures to minimize potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left ventricular function after noninvasive cardiac ablation using proton beam therapy in a porcine model. Hohmann, S., Deisher, AJ., Suzuki, A., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Cardiac stereotactic ablative radiotherapy for control of refractory ventricular tachycardia: initial UK multicentre experience. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Catheter ablation of hemodynamically unstable ventricular tachycardia in ischemic cardiomyopathy using high-resolution mapping. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Non-invasive Stereotactic Radioablation: A New Option for the Treatment of Ventricular Arrhythmias. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic radioablation for ventricular tachycardia. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA). [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Left ventricular function after noninvasive cardiac ablation using proton beam therapy in a porcine model. [2020]