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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≥ 18 years and ≤ 75 years at time of enrollment consent

• Subject has a diagnosis of IST

• 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

• Subject is willing and able to provide written informed consent

Locations
United States
California
Loma Linda University Health
RECRUITING
Loma Linda
Sequoia Hospital
RECRUITING
Redwood City
Stanford University
RECRUITING
Redwood City
Connecticut
Saint Vincent's Medical Center
RECRUITING
Bridgeport
Washington, D.c.
Medstar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
University of Florida
RECRUITING
Gainesville
Baptist Health
WITHDRAWN
Miami
Sarasota Memorial Hospital
RECRUITING
Sarasota
St. Joseph's Hospital / Baycare Health System
RECRUITING
Tampa
Georgia
Memorial Health University Medical Center
RECRUITING
Savannah
Idaho
Saint Alphonsus Regional Medical Center
WITHDRAWN
Boise
Kansas
Kansas City Cardiac Arrhythmia Research LLC
RECRUITING
Overland Park
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Ohio
The Christ Hospital
RECRUITING
Cincinnati
TriHealth, Inc.
RECRUITING
Cincinnati
Texas
Texas Cardiac Arrhythmia Research Foundation
RECRUITING
Austin
Utah
Intermountain Healthcare
RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Belgium
UZ Brussels
RECRUITING
Brussels
Italy
San Raffaele Hospital
RECRUITING
Milan
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Maastricht University Medical Center
RECRUITING
Maastricht
Poland
Central Clinic Hospital
RECRUITING
Warsaw
United Kingdom
Northern General Hospital
RECRUITING
Sheffield
Contact Information
Primary
Joseph Derr
jderr@atricure.com
1 (866) 349-2342
Backup
Kirstin Smentek
ksmentek@atricure.com
1 (866) 349-2342
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2027-06
Participants
Target number of participants: 142
Treatments
Experimental: Hybrid sinus node sparing ablation procedure
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Sponsors
Leads: AtriCure, Inc.

This content was sourced from clinicaltrials.gov