What side effects are associated with this type of intervention?

Common treatments for Inappropriate Sinus Tachycardia (IST) include medications such as beta-blockers and calcium channel blockers, which can cause side effects like fatigue, dizziness, and hypotension. Catheter ablation, a procedure that modifies electrical pathways in the heart, can lead to complications such as bleeding, infection, and damage to the heart's electrical system, potentially resulting in arrhythmias. The hybrid sinus node sparing ablation procedure aims to control heart rate while preserving the sinus node, but it may still carry risks of procedural complications and arrhythmias.

What prior FDA approvals exist?

Inappropriate Sinus Tachycardia (IST) is a challenging condition with limited FDA-approved treatments. Traditional management includes beta-blockers and calcium channel blockers, which aim to control heart rate but often have limited efficacy and tolerability. Ivabradine, a selective sinus node inhibitor, has been used off-label for IST. The hybrid sinus node sparing ablation procedure, currently under investigation, represents a novel approach by modifying electrical pathways to control heart rate while preserving sinus node function. This procedure aims to offer a more targeted and potentially effective treatment option for patients with drug-refractory or drug-intolerant IST.

What other types of research exist?

Promising novel alternatives to the Hybrid Sinus Node Sparing Ablation Procedure for IST patients include: 1) Advanced multi-channel gastric electrical stimulation, which has shown efficacy in modulating neural pathways and could potentially be adapted for cardiac applications. 2) Newer catheter ablation techniques, such as those using high-resolution mapping and impedance-based feedback control, which offer precise targeting of arrhythmogenic foci while minimizing damage to surrounding tissues. 3) Implantable devices that provide real-time monitoring and adaptive pacing, which can dynamically adjust heart rate based on physiological needs. These alternatives are still under investigation but show potential for improved management of IST.

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Procedure

Surgical Ablation for Rapid Heartbeat

N/A

Recruiting

Led By Carlo de Asmundis, MD

Research Sponsored by AtriCure, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years and ≤ 75 years at time of enrollment consent

Subject has a diagnosis of IST

Must not have

Subjects on whom cardiac surgery or single lung ventilation cannot be performed

Previous cardio-thoracic surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new procedure that treats fast heartbeats without damaging the heart's natural pacemaker. It is aimed at patients with Inappropriate Sinus Tachycardia (IST) who do not respond to or cannot tolerate medications. The procedure works by carefully modifying parts of the heart to correct the abnormal rhythm.

Who is the study for?

This trial is for adults aged 18-75 with Inappropriate Sinus Tachycardia (IST) who haven't responded to or can't tolerate certain heart rate control drugs. Participants must be able to consent and commit to follow-up visits. Exclusions include those with pacemakers, previous heart surgery, severe other conditions, drug abuse, BMI ≥ 35, or life expectancy under 2 years.

What is being tested?

The HEAL-IST IDE Trial is testing the AtriCure ISOLATOR Synergy Surgical Ablation System's safety and effectiveness in treating symptomatic IST that doesn't improve with medication. The procedure aims to preserve the sinus node while addressing rapid heartbeat issues.

What are the potential side effects?

Potential side effects may include complications from cardiac surgery such as bleeding, infection risk at the incision site, possible damage to surrounding heart tissue during ablation leading to arrhythmias or need for a pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have been diagnosed with IST.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo cardiac surgery or single lung ventilation.

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I have had heart or lung surgery in the past.

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I have a fast heartbeat that starts in the upper or lower chambers of my heart.

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I have been diagnosed with POTS.

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I was born with a heart condition.

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I have had a procedure to correct heart rhythm issues in the right atrium.

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I have had weight loss surgery in the past.

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I cannot commit to returning for follow-up visits.

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I am legally able to make my own decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary study objectives

6-Minute Walk Test

Borg dyspnea score

Device or procedure related Serious Adverse Events

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hybrid sinus node sparing ablation procedureExperimental Treatment1 Intervention

Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Inappropriate Sinus Tachycardia (IST) is often treated by modifying the electrical pathways in the heart to control the heart rate. The Hybrid Sinus Node Sparing Ablation Procedure, for example, targets specific areas of the heart to alter abnormal electrical signals that cause rapid heart rates, while sparing the sinus node to maintain normal heart rhythm. This is crucial for IST patients as it helps to manage symptoms like palpitations and fatigue without compromising the heart's natural pacemaker, thereby improving quality of life and reducing the risk of complications associated with more invasive treatments.