What this study is
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.
What's being tested
- AtriCure Commercially Available Devices
Intervention · DEVICE
Epicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.
Study details
- Official title
- A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
- Sponsor
- AtriCure, Inc.
- Conditions
- Inappropriate Sinus Tachycardia · Postural Tachycardia Syndrome
- Enrolling
- 500 people
- Starts
- 2022-03-01
- Est. completion
- 2030-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (15)
15 openLoma Linda University Health
Loma Linda, California, United States
- Kisha-Nicole Hefflin · Contact909-651-9865khefflin@llu.edu
- Jalaj Garg, MD · Principal investigator
RecruitingStanford University
Palo Alto, California, United States
- Tiffany Koyano · Contact650-724-6921tkoyano3@stanford.edu
- Anson Lee · Principal investigator
RecruitingSequoia Hospital
Redwood City, California, United States
- Juanita Fuji · Contact650-482-6131Juanita.fujii@commonspirit.org
- Chad Brodt · Principal investigator
RecruitingUniversity of Florida
Gainesville, Florida, United States
- Jessica Cobb · Contact352-514-3729Jessica.cobb@surgery.ufl.edu
- Thomas Beaver · Principal investigator
RecruitingHCA Osceola Regional Medical Center
Kissimmee, Florida, United States
- Mary Janette Sendin · Contactmary.sendin@hcahealthcare.com
- Steven Hoff, MD · Principal investigator
RecruitingSarasota Memorial Hospital
Sarasota, Florida, United States
- Alexandra Gardner · Contact941-917-8791Alexandra-Gardner@smh.com
- Paul Vesco · Principal investigator
RecruitingKansas City Cardiac Arrhythmia Research
Kansas City, Kansas, United States
- Donita Atkins · Contact913-934-4313Donita.Atkins@hcahealthcare.com
- Dhanunjaya Lakkireddy · Principal investigator
RecruitingMedStar Health Research Institute
Hyattsville, Maryland, United States
- Katherine Mahoney · Contact202-877-2806katharine.e.mahoney@medstar.net
- Thomaides Athanasios · Sub-investigator
RecruitingThe Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
- Anne Voorhorst · Contact513-585-1777Anne.Voorhorst@thechristhospital.com
- Michael Smith · Principal investigator
RecruitingTexas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
- Chantel Scallon · Contact512-807-3150cmscallon@austinheartbeat.com
- Andrea Natale · Principal investigator
RecruitingIntermountain Medical Center
Murray, Utah, United States
- Lindsey Beven · Contact801-507-4889Lindsey.Bevan@imail.org
- John Doty · Principal investigator
RecruitingSwedish Health Services
Seattle, Washington, United States
- Faith Otewa · Contact206-215-3982faith.otewa@swedish.org
- Eric Lehr, MD · Principal investigator
Recruiting
3 sites outside the US
Universitair Ziekenhuis Brussels
Brussels, Belgium
- Iris Vanzeebroeck · Contact02/476 35 09iris.vanzeebroeck@uzbrussel.be
- Carlo de Asmundis, MD PhD · Principal investigator
RecruitingIRCCS Ospedale San Raffaele
San Raffaele, Italy
- Davide Schiavi · Contact+39 0226431schiavi.davide@hsr.it
- Lapenna Elisabetta · Principal investigator
RecruitingCentral Clinic Hospital
Warsaw, Poland
- Monika Pawelec · Contact+48 722 22 33monika.pawelec@pimmswia.gov.pl
- Piotr Suwalski · Principal investigator
Recruiting
Study team
Sponsor
AtriCure, Inc.
Study ID RP-2021-IST
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.