HEAL-IST IDE Trial

December 29, 2023 updated by: AtriCure, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
        • Principal Investigator:
          • Bart Maesen, MD
        • Sub-Investigator:
          • Dominik Linz, MD
        • Sub-Investigator:
          • Marisevi Chaldoupi, MD
  • United States
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anson Lee, MD
        • Sub-Investigator:
          • Nitish Badhwar, MD
        • Sub-Investigator:
          • Albert J Rogers, MD
      • Redwood City, California, United States, 94062
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • Athanasios Thomaides, MD
        • Principal Investigator:
          • Christian Shults, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Thomas Beaver, MD
        • Contact:
        • Sub-Investigator:
          • Kun Xiang, MD
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Vesco, MD
        • Sub-Investigator:
          • Dilip Mathew, MD
    • Georgia
      • Savannah, Georgia, United States, 31404
    • Idaho
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Cardiac Arrhythmia Research LLC
        • Principal Investigator:
          • Dhanunjaya Lakkireddy, M.D.
        • Sub-Investigator:
          • Ahmed Romeya, M.D.
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arman Arghami, MD
        • Principal Investigator:
          • Ammar Killu, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Patrick Whalen, MD
        • Sub-Investigator:
          • Prashant Bhave, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • J Michael Smith, MD
        • Contact:
        • Sub-Investigator:
          • Daniel Pelchovitz, MD
      • Cincinnati, Ohio, United States, 45202
        • Recruiting
        • TriHealth, Inc.
        • Principal Investigator:
          • Gaurang Gandhi, MD
        • Sub-Investigator:
          • Eric Okum, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research Foundation
        • Principal Investigator:
          • Andrea Natale, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Faraz Kerendi, MD
        • Sub-Investigator:
          • David Tschopp, MD
    • Utah
      • Salt Lake City, Utah, United States, 84111
        • Recruiting
        • Intermountain Healthcare
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Cutler, MD
        • Sub-Investigator:
          • Brian Crandall, MD
        • Sub-Investigator:
          • Peter Smit, MD
        • Sub-Investigator:
          • John Doty, MD
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Vigneshwar Kasirajan, MD
        • Sub-Investigator:
          • Jayanthi Koneru, MD
        • Sub-Investigator:
          • Kenneth Ellenbogen, MD
        • Sub-Investigator:
          • Arturo Cardounel, MD
    • Washington
      • Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 75 years at time of enrollment consent
  2. Subject has a diagnosis of IST
  3. Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs
  4. Subject is willing and able to provide written informed consent

Exclusion Criteria:

  1. Subjects on whom cardiac surgery or single lung ventilation cannot be performed
  2. Subjects with indication for or existing ICDs/Pacemakers
  3. Presence of channelopathies
  4. Previous cardio-thoracic surgery
  5. Left Ventricular Ejection Fraction (LVEF) < 50%
  6. Body Mass Index (BMI) ≥ 35
  7. Presence of supraventricular or ventricular tachycardia
  8. Presence of Postural Orthostatic Sinus Tachycardia (POTS)
  9. Presence of congenital heart disease
  10. History suggestive of secondary cause of tachycardia such as pheochromocytoma, anemia, thyrotoxicosis, chronic fever of unknown origin, COPD, long-term bronchodilators use, severe asthma or carcinoid syndrome
  11. Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
  12. Life expectancy < 24 months
  13. Pregnant or planning to become pregnant during trial
  14. Subjects with substance abuse
  15. Subjects with previous weight loss surgery
  16. Subject is unwilling and/or unable to return for scheduled follow-up visits
  17. Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a trial that may interfere with trial results
  18. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
  19. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid sinus node sparing ablation procedure
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Device: AtriCure ISOLATOR Synergy Surgical Ablation System
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 12-months Post Procedure
Freedom from IST at 12-months. Freedom from IST is defined as mean heart rate of ≤ 90bpm or at least a 15% reduction in mean heart rate as compared to baseline, in the absence of new or higher dosage of previously failed medications.
12-months Post Procedure
Primary Safety Endpoint
Time Frame: 30-days Post Procedure
Incidence of device or procedure-related major adverse events (MAEs) for subjects undergoing the hybrid sinus node sparing ablation procedure from the index procedure through 30-days post procedure
30-days Post Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test
Time Frame: 24-months Post Procedure
Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure
24-months Post Procedure
Borg dyspnea score
Time Frame: 24-months Post Procedure
Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score will be assessed at each of the 6-MWT.
24-months Post Procedure
Self-Rating Anxiety Scale
Time Frame: 24-months Post Procedure
Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)
24-months Post Procedure
IST symptom reduction
Time Frame: 24-months Post Procedure
IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure
24-months Post Procedure
QoL - SF-12
Time Frame: 24-months Post Procedure
Change in QoL based on a Short Form Survey (SF-12) domain and component scores at baseline compared to 6-, 12- and 24-months post-procedure
24-months Post Procedure
Mean heart rate
Time Frame: 24-months Post Procedure
Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring
24-months Post Procedure
Reduction in mean heart rate in the absence of rate control drugs
Time Frame: 24-months Post Procedure
Freedom from IST or at least 15% reduction in mean heart rate at 12- and 24-months compared to baseline, in the absence of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs
24-months Post Procedure
Reduction in mean heart rate regardless of rate control drugs
Time Frame: 24-months Post Procedure
Freedom from IST or at least a 15% reduction in mean heart rate at 12- and 24-months compared to baseline, regardless of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs
24-months Post Procedure
Device or procedure related Serious Adverse Events
Time Frame: 12-months Post Procedure
Device or procedure related Serious Adverse Events (SAEs) through 12-months
12-months Post Procedure
Improved heart rate variability - 7-day monitor
Time Frame: 12-months Post Procedure
Improved heart rate variability for subjects using 7-day continuous monitoring
12-months Post Procedure
Improved heart rate variability - Implantable loop recorder
Time Frame: 12-months Post Procedure
Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)
12-months Post Procedure
Health Economics
Time Frame: 24-months Post Procedure
Health Economics: ER visits and readmissions
24-months Post Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
  • Principal Investigator: Mark La Meir, MD, Universitair Ziekenhuis Brussel
  • Principal Investigator: Carlo de Asmundis, MD, Universitair Ziekenhuis Brussel
  • Principal Investigator: Thomas Beaver, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2021-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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