Inappropriate Sinus TachycardiaNCT05107635
Inappropriate Sinus Tachycardia Registry
An observational study of Inappropriate Sinus Tachycardia and Postural Tachycardia Syndrome, run by AtriCure, Inc. at 15 sites in 4 countries.
Trial summary
The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome
- What is being tested?
- AtriCure Commercially Available Devices
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 1 Mar 2022to Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias.
Who may be able to join
- Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.
- Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements
Who cannot join
- Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
- Subject with exclusion criteria required by FDA or local governance
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 4 countries
United States12 sites, 12 recruiting
- Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Chantel Scallon, 512-807-3150, cmscallon@austinheartbeat.com
Andrea Natale
- Recruiting
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
Anne Voorhorst, 513-585-1777, Anne.Voorhorst@thechristhospital.com
Michael Smith
- Recruiting
University of Florida
Gainesville, Florida, 32608
Jessica Cobb, 352-514-3729, Jessica.cobb@surgery.ufl.edu
Thomas Beaver
- Recruiting
MedStar Health Research Institute
Hyattsville, Maryland, 20782
Katherine Mahoney, 202-877-2806, katharine.e.mahoney@medstar.net
Thomaides Athanasios
- Recruiting
Kansas City Cardiac Arrhythmia Research
Kansas City, Kansas, 64132
Donita Atkins, 913-934-4313, Donita.Atkins@hcahealthcare.com
Dhanunjaya Lakkireddy
- Recruiting
HCA Osceola Regional Medical Center
Kissimmee, Florida, 34741
Mary Janette Sendin, mary.sendin@hcahealthcare.com
Steven Hoff, MD
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
Kisha-Nicole Hefflin, 909-651-9865, khefflin@llu.edu
Jalaj Garg, MD
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Lindsey Beven, 801-507-4889, Lindsey.Bevan@imail.org
John Doty
- Recruiting
Stanford University
Palo Alto, California, 94305
Tiffany Koyano, 650-724-6921, tkoyano3@stanford.edu
Anson Lee
- Recruiting
Sequoia Hospital
Redwood City, California, 94062
Juanita Fuji, 650-482-6131, Juanita.fujii@commonspirit.org
Chad Brodt
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Alexandra Gardner, 941-917-8791, Alexandra-Gardner@smh.com
Paul Vesco
- Recruiting
Swedish Health Services
Seattle, Washington, 98122
Faith Otewa, 206-215-3982, faith.otewa@swedish.org
Eric Lehr, MD
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussels
Brussels
Iris Vanzeebroeck, 02/476 35 09, iris.vanzeebroeck@uzbrussel.be
Carlo de Asmundis, MD PhD
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
San Raffaele
Davide Schiavi, +39 0226431, schiavi.davide@hsr.it
Lapenna Elisabetta
Poland1 site, 1 recruiting
- Recruiting
Central Clinic Hospital
Warsaw, 02-507
Monika Pawelec, +48 722 22 33, monika.pawelec@pimmswia.gov.pl
Piotr Suwalski
About this study
Official title: A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry.
- Being tested
- AtriCure Commercially Available Devices
- Keywords
- Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome;, Sinus Node Sparing Hybrid Procedure
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriCure Commercially Available DevicesDevice
Epicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
AtriCure commercially available devices used to treat IST or POTS
The IST Registry will attempt to enroll all eligible patients at registry sites who have already had or are scheduled to have a procedure to treat IST/POTS that includes the use of at least one commercially available AtriCure cardiac ablation devices.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Mar 2022
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate Sinus TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107635
- Sponsor's protocol ID
- RP-2021-IST
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
- ClinicalTrials.gov ID
- NCT05107635
- Acronym / sponsor ID
- RP-2021-IST
- Keywords
- Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome;, Sinus Node Sparing Hybrid Procedure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias.
Key inclusion criteria (2 listed)
- Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.
- Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements
Key exclusion criteria (2 listed)
- Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
- Subject with exclusion criteria required by FDA or local governance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtriCure Commercially Available DevicesEpicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices. | Device | – |
Primary outcome
AtriCure commercially available devices used to treat IST or POTS
Time frame: 5 years
The IST Registry will attempt to enroll all eligible patients at registry sites who have already had or are scheduled to have a procedure to treat IST/POTS that includes the use of at least one commercially available AtriCure cardiac ablation devices.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Inappropriate Sinus Tachycardia
Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
Not yet recruiting
Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Cardiac Dysautonomia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inappropriate Sinus Tachycardia and Postural Tachycardia Syndrome, run by AtriCure, Inc. at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Registry Specialist (866-349-2342, IST-Registry@atricure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AtriCure commercially available devices used to treat IST or POTS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.