Clinical trial for inappropriate sinus tachycardia IST Dysautonomia POTS ablation or resting heart rate 100 bpm

About HEAL-IST

The HEAL-IST Trial is recruiting participants to evaluate the safety and effectiveness of a hybrid sinus node sparing procedure to treat patients with symptomatic drug refractory or drug intolerant inappropriate sinus tachycardia or IST.

What is Inappropriate Sinus Tachycardia or IST?

IST is a complex heart condition that occurs in otherwise healthy younger people and causes rapid heart rates of over 100 bpm, even at rest.

Common symptoms of inappropriate sinus tachycardia include:
  • Palpitations - fluttering or pounding sensations in your chest
  • Chest discomfort 
  • Weakness or dizziness 
  • Lightheadedness or fainting 
  • Shortness of breath 
  • Fatigue 
  • Anxiety 
  • Exaggerated response to exercise or stress

These symptoms can affect day-to-day activities and can diminish one’s quality of life. There are currently no FDA-approved therapies to treat inappropriate sinus tachycardia. However, a hybrid sinus node sparing ablation is being studied as a potential new treatment option for patients who suffer from symptomatic, drug-resistant or intolerant IST.

 

More Videos...

How POTS Differs from IST

Postural Orthostatic Tachycardia Syndrome (POTS) is another type of heart condition. Although patients with POTS can experience similar symptoms to inappropriate sinus tachycardia like lightheadedness, shortness of breath, fatigue and anxiety, a key difference between POTS and IST is resting heart rate. Individuals with POTS typically have a resting heart rate of 90 bpm or less, whereas those with IST have a resting heart rate usually greater than 100 bpm.

Dr. Rani Kronenberger (University Hospital, Brussels, Belgium) describes key differences between IST and POTS and introduces the hybrid ablation procedure to treat IST.

 

Are you a candidate for the HEAL-IST Trial?

  • You are between 18 and 75 years of age
  • You have already been diagnosed with IST
  • You are willing and able to receive all the trial-related procedures and go to the scheduled follow-up visits over a 2-year period of time
  • You are willing to provide written informed consent for the trial

Your trial doctor or research staff will determine if you qualify for the HEAL-IST Trial.

Patient Information Guide

What is the Hybrid Ablation Procedure?

A novel sinus node sparing procedure is being evaluated in the HEAL-IST Trial. Designed to spare the sinoatrial node, the heart’s natural pacemaker, this procedure involves creating lesions along certain areas of the heart’s outside surface and sometimes inside the heart with the goal of lowering the rapid heart rate responsible for IST.

Hospital Centers That Are Currently Recruiting Participants

US Sites/Hospital
State
City
Physician:

Chad Brodt, MD

Physician:

Gansevoort Dunnington, MD

Physician:

Luis Castro, MD

Physician:

Justin C Lee, MD

Physician:

AJ Rogers, MD

Physician:

Joshua Chung, MD

Physician:

Rahul Bhardwaj, MD

Physician:

Jalaj Garg, MD

Research Coordinator:

Kimberly Gilfillan

Physician:

Joseph Tiano, MD

Physician:

Daniel Fusco, MD

Physician:

Paul Vesco, MD

Physician:

Dilip Mathew, MD

Research Coordinator:

Colleen Lindner

[email protected]

Research Coordinator:

Scarleth Funez

[email protected]

Research Coordinator:

Jennifer Jordan

[email protected]

941-917-5916

Physician:

Thomas Beaver, MD

Physician:

Kun Xiang, MD PhD

Physician:

Vilma Torres, MD

Physician:

William Miles, MD

Research Coordinator:

Magdalyn Bassetti

[email protected]

Physician:

Andrew Sherman MD

Physician:

Kevin Makati, MD

Research Coordinator:

Arielle Campos, RN

[email protected]

813-533-1418 and 813-840-3600

Physician:

David Newton, MD

Research Coordinator:

Alta Castellino

[email protected]

912-350-0414

Physician:

Dhanunjaya Lakkireddy, MD

Physician:

Ahmed Romeya, MD

Study Coordinator (Lead):

Donita Atkins

[email protected]

913-449-1297

Physician:

Arman Arghami, MD

Physician:

Ammar Killu, MBBS

Research Coordinator:

Joseph Abdel Messih

[email protected]

Physician:

Patrick Whalen, MD

Physician:

Edward H Kincaid, MD

Physician:

Michael Smith, MD

Physician:

Daniel Pelchovitz, MD

Physician:

Andrew Noll, MD

Research Coordinator:

Anne Voorhorst

[email protected]

513-585-1777

Research Coordinator:

Susan Reilly

[email protected]

513-585-1777

Physician:

Gaurang Gandhi, MD

Physician:

Eric Okum, MD

Physician:

Marshall Winner, MD

Physician:

Hemal Shah, MD

Research Manager:

Kelly Blackwell

[email protected]

513-865-1148

Physician:

Andrea Natale, MD

Physician:

Faraz Kerendi, MD

Physician:

David Tschopp, MD

Research Coordinator:

Deb Cardinal

[email protected]

512-522-9410

Research Coordinator:

Chantel Scallon

[email protected]

Research Coordinator:

Susan Suarez

[email protected]

Physician:

John Doty, MD

Physician:

Michael Cutler, DO

[email protected]

801-507-7000

Physician:

Brian Crandall, MD

Physician:

Vigneshwar Kasirajan, MD

Physician:

Kenneth Ellenbogen, MD

Physician:

Jayanthi Koneru, MD

Physician:

Eric Lehr, MD PhD

Physician:

Darryl Wells, MD

Physician:

Athanasios Thomaides, MD

Physician:

Christian Shults, MD

Research Coordinator:

Kate Mahoney

[email protected]

Research Coordinator:

Nebu Alexander

[email protected]

International Sites
Country
City
Physician:

Carlo de Asmundis, Prof

Physician:

Mark La Meir, MD

Research Coordinator:

Iris Vanzeebroeck

[email protected]

02 476 35 09

Research Coordinator:

Ileana Smets

[email protected]

02 477 5660

Physician:

Bart Maesen, MD PhD

Physician:

Dominik Linz, PhD

Physician:

Joris de Groot, MD

Physician:

Antonius Driessen, MD

Physician:

Marc Terpstra, MD

Research Coordinator:

Elise Hulsman

Physician:

Jonathan Sahu, MD

[email protected]

Physician:

Steven Hunter, MD

Research Coordinator:

Liam Haslam

[email protected]

Research Coordinator:

Joann Barker

[email protected]

0114  2715779

0114  2434343/0114 27 11900

Physician:

Manuela Cireddu, MD

Physician:

Elisabetta Lapenna, MD

Research Coordinator:

Davide Schiavi

Research Coordinator:

Anna Montagna

Physician:

Piotr Suwalski, MD

Physician:

Sebastian Stec, MD

Physician:

Mariusz Kowalewski, MD

Research Coordinator:

Klaudia Stachura


Click here for more information on clinicaltrials.gov

Physician Videos

Why Are You Passionate About Treating IST?

Drs. Chad R Brodt, Gaurang D. Gandhi, Anson M Lee, and Thomas M Beaver discuss why they are passionate about treating patients with symptomatic inappropriate sinus tachycardia.

Treatment Options for IST

Drs. Chad R. Brodt, Anson M. Lee and Thomas M Beaver provide a historical perspective on treating inappropriate sinus tachycardia as well as discuss a new hybrid therapy approach and collaborative care for managing patients with IST.

Thomas M. Beaver, MD, MPH

Dr. Beaver discusses the impact to quality of life in patients suffering from symptomatic inappropriate sinus tachycardia as well as treatment options and an overview of the hybrid ablation procedure.

Mark La Meir, MD, PhD

Professor La Meir describes typical symptoms of inappropriate sinus tachycardia, the hybrid ablation procedure and what it means to have a hybrid team approach for the treatment of IST.

DJ Lakkireddy, MD

Hear how Dr. Dhanunjaya (DJ) Lakkireddy describes patients who suffer from inappropriate sinus tachycardia and what medications have been used to treat symptoms of IST.

Carlo de Asmundis, MD, PhD

Professor de Asmundis walks through common symptoms of inappropriate sinus tachycardia and the hybrid team approach for the treatment of IST.

Key Publications


Sinus Node Sparing Approach

Structural Mechanisms

Etiology and Management

IST and POTs

SUSRUTA Registry

 

PM-US-2022I-0327-G