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Procedure

Surgical Ablation for Rapid Heartbeat

N/A

Recruiting

Led By Dhanunjaya Lakkireddy, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-months post procedure

Awards & highlights

Study Summary

This trial is testing a new ablation procedure to treat IST, a condition that causes significant loss of quality of life.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary outcome measures

6-Minute Walk Test

Borg dyspnea score

Device or procedure related Serious Adverse Events

+9 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AtriCure, Inc.Lead Sponsor

41 Previous Clinical Trials

17,329 Total Patients Enrolled

1 Trials studying Inappropriate Sinus Tachycardia

500 Patients Enrolled for Inappropriate Sinus Tachycardia

Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Heart Rhythm Institute

28 Previous Clinical Trials

8,082 Total Patients Enrolled

Mark La Meir, MDPrincipal InvestigatorUniversitair Ziekenhuis Brussel

Media Library

AtriCure ISOLATOR Synergy Surgical Ablation System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05280093 — N/A

Inappropriate Sinus Tachycardia Research Study Groups: Hybrid sinus node sparing ablation procedure

Inappropriate Sinus Tachycardia Clinical Trial 2023: AtriCure ISOLATOR Synergy Surgical Ablation System Highlights & Side Effects. Trial Name: NCT05280093 — N/A

AtriCure ISOLATOR Synergy Surgical Ablation System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280093 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research endeavor currently seeking participants?

"Clinicaltrials.gov reveals that this medical experiment, which was initially posted on May 31st 2022, is no longer recruiting individuals for participation. However, there are 122 other clinical studies still searching for volunteers at the present moment."

Answered by AI

Am I eligible to take part in this scientific experiment?

"Those who meet the criteria for admission—heart rate greater than 100 BPM, sinus rhythm, aged between 18 and 75 years old—are invited to apply for this medical trial which aims to recruit 142 participants."

Answered by AI

What can we expect to be achieved through the completion of this experiment?

"This 30-day study has a primary objective of assessing effectiveness. Secondary objectives include measuring the change in 6-Minute Walk Test, heart rate with 7-days' continuous monitoring, and Borg dyspnea score at each 6 Minute Walk Test interval (baseline compared to 6-, 12-, and 24 months post procedure)."

Answered by AI

Does this clinical research require participants to be of legal age?

"This clinical trial's criteria for patient recruitment indicates that individuals aged 18-75 are eligible to partipcate. Additionally, there are 14 studies being conducted with minors and 97 studies aimed at patients over the age of retirement."

Answered by AI