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ACTIVE NOT RECRUITING
NCT05280093
NA

HEAL-IST IDE Trial

Sponsor: AtriCure, Inc.

View on ClinicalTrials.gov

Summary

Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST.

Official title: Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2022-05-31

Completion Date

2028-02

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DEVICE

AtriCure ISOLATOR Synergy Surgical Ablation System

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

Locations (27)

St. Bernard

Jonesboro, Arkansas, United States

Loma Linda University Health

Loma Linda, California, United States

Sequoia Hospital

Redwood City, California, United States

Stanford University

Redwood City, California, United States

Saint Vincent's Medical Center

Bridgeport, Connecticut, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Baptist Health

Miami, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

St. Joseph's Hospital / Baycare Health System

Tampa, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, United States

Mayo Clinic

Rochester, Minnesota, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

TriHealth, Inc.

Cincinnati, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

UZ Brussels

Brussels, Belgium

San Raffaele Hospital

Milan, Italy

Amsterdam University Medical Center

Amsterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Central Clinic Hospital

Warsaw, Poland

Northern General Hospital

Sheffield, United Kingdom