Back to resultsHEAL-IST IDE Trial
Primary Purpose
Inappropriate Sinus Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AtriCure ISOLATOR Synergy Surgical Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Inappropriate Sinus Tachycardia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subjects on whom cardiac surgery or single lung ventilation cannot be performed
- Subjects with indication for or existing ICDs/Pacemakers
- Presence of channelopathies
- Previous cardio-thoracic surgery
- Left Ventricular Ejection Fraction (LVEF) < 50%
- Body Mass Index (BMI) ≥ 35
- Presence of supraventricular or ventricular tachycardia
- Presence of Postural Orthostatic Sinus Tachycardia (POTS)
- Presence of congenital heart disease
- 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
- Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
- Life expectancy < 24 months
- Pregnant or planning to become pregnant during trial
- Subjects with substance abuse
- Subjects with previous weight loss surgery
- Subject is unwilling and/or unable to return for scheduled follow-up visits
- 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
- Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
- 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
Sites / Locations
- Sequoia HospitalRecruiting
- Stanford UniversityRecruiting
- Medstar Washington Hospital CenterRecruiting
- University of FloridaRecruiting
- Sarasota Memorial HospitalRecruiting
- Memorial Health University Medical CenterRecruiting
- Saint Alphonsus Regional Medical CenterRecruiting
- Kansas City Cardiac Arrhythmia Research LLCRecruiting
- Mayo ClinicRecruiting
- Wake Forest University Health SciencesRecruiting
- TriHealth, Inc.Recruiting
- The Christ HospitalRecruiting
- Intermountain HealthcareRecruiting
- Virginia Commonwealth UniversityRecruiting
- Swedish Medical CenterRecruiting
- UZ BrusselsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hybrid sinus node sparing ablation procedure
Arm Description
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Outcomes
Primary Outcome Measures
Primary Effectiveness Endpoint
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.
Primary Safety Endpoint
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
Secondary Outcome Measures
6-Minute Walk Test
Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure
Borg dyspnea score
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.
Self-Rating Anxiety Scale
Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)
IST symptom reduction
IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure
QoL - SF-12
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
Mean heart rate
Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring
Reduction in mean heart rate in the absence of rate control drugs
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
Reduction in mean heart rate regardless of rate control drugs
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
Device or procedure related Serious Adverse Events
Device or procedure related Serious Adverse Events (SAEs) through 12-months
Improved heart rate variability - 7-day monitor
Improved heart rate variability for subjects using 7-day continuous monitoring
Improved heart rate variability - Implantable loop recorder
Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)
Health Economics
Health Economics: ER visits and readmissions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05280093
Brief Title
HEAL-IST IDE Trial
Official Title
Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inappropriate Sinus Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hybrid sinus node sparing ablation procedure
Arm Type
Experimental
Arm Description
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Intervention Type
Device
Intervention Name(s)
AtriCure ISOLATOR Synergy Surgical Ablation System
Intervention Description
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
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.
Time Frame
12-months Post Procedure
Title
Primary Safety Endpoint
Description
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
Time Frame
30-days Post Procedure
Secondary Outcome Measure Information:
Title
6-Minute Walk Test
Description
Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure
Time Frame
24-months Post Procedure
Title
Borg dyspnea score
Description
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.
Time Frame
24-months Post Procedure
Title
Self-Rating Anxiety Scale
Description
Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)
Time Frame
24-months Post Procedure
Title
IST symptom reduction
Description
IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure
Time Frame
24-months Post Procedure
Title
QoL - SF-12
Description
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
Time Frame
24-months Post Procedure
Title
Mean heart rate
Description
Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring
Time Frame
24-months Post Procedure
Title
Reduction in mean heart rate in the absence of rate control drugs
Description
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
Time Frame
24-months Post Procedure
Title
Reduction in mean heart rate regardless of rate control drugs
Description
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
Time Frame
24-months Post Procedure
Title
Device or procedure related Serious Adverse Events
Description
Device or procedure related Serious Adverse Events (SAEs) through 12-months
Time Frame
12-months Post Procedure
Title
Improved heart rate variability - 7-day monitor
Description
Improved heart rate variability for subjects using 7-day continuous monitoring
Time Frame
12-months Post Procedure
Title
Improved heart rate variability - Implantable loop recorder
Description
Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)
Time Frame
12-months Post Procedure
Title
Health Economics
Description
Health Economics: ER visits and readmissions
Time Frame
24-months Post Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Subjects on whom cardiac surgery or single lung ventilation cannot be performed
Subjects with indication for or existing ICDs/Pacemakers
Presence of channelopathies
Previous cardio-thoracic surgery
Left Ventricular Ejection Fraction (LVEF) < 50%
Body Mass Index (BMI) ≥ 35
Presence of supraventricular or ventricular tachycardia
Presence of Postural Orthostatic Sinus Tachycardia (POTS)
Presence of congenital heart disease
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
Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
Life expectancy < 24 months
Pregnant or planning to become pregnant during trial
Subjects with substance abuse
Subjects with previous weight loss surgery
Subject is unwilling and/or unable to return for scheduled follow-up visits
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
Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Derr
Phone
5084502120
Email
jderr@atricure.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Smentek
Phone
612.430.1398
Email
ksmentek@atricure.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
Kansas City Heart Rhythm Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark La Meir, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlo de Asmundis, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Beaver, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zayna Shaheen
Email
zayna.shaheen@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Juanita Fujii
Phone
650-482-6131
Email
juanita.fujii@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Chad Brodt, MD
First Name & Middle Initial & Last Name & Degree
Luis Castro, MD
First Name & Middle Initial & Last Name & Degree
Gan Dunnington, MD
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Koyano
Phone
650-724-6921
Email
tkoyano3@stanford.edu
First Name & Middle Initial & Last Name & Degree
Tiffany Flores
Phone
650-725-8718
Email
tflores2@stanford.edu
First Name & Middle Initial & Last Name & Degree
Anson Lee, MD
First Name & Middle Initial & Last Name & Degree
Nitish Badhwar, MD
First Name & Middle Initial & Last Name & Degree
Albert J Rogers, MD
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Mahoney
Phone
202-877-2806
Email
katharine.e.mahoney@medstar.net
First Name & Middle Initial & Last Name & Degree
Christian Shults, MD
First Name & Middle Initial & Last Name & Degree
Athanasios Thomaides, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Cobb, PhD
Phone
352-273-7837
Email
jessica.cobb@surgery.ufl.edu
First Name & Middle Initial & Last Name & Degree
Thomas Beaver, MD
First Name & Middle Initial & Last Name & Degree
Kun Xiang, MD
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Lindner
Phone
941-917-1669
Email
colleen-lindner@smh.com
First Name & Middle Initial & Last Name & Degree
Alexandra Gardner
Phone
941-917-5916
Email
alexandra-gardner@smh.com
First Name & Middle Initial & Last Name & Degree
Paul Vesco, MD
First Name & Middle Initial & Last Name & Degree
Dilip Mathew, MD
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alta Castellino
Phone
912-350-0414
Email
alta.castellino@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Adrienne Garbe
Email
adrienne.garbe@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Chadwick Stouffer, MD
First Name & Middle Initial & Last Name & Degree
David Newton, MD
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Furlipa
Phone
208-302-0066
Email
joy.furlipa@saintalphonsus.org
First Name & Middle Initial & Last Name & Degree
Jonathan Youell
Email
Jonathan.Youell@saintalphonsus.org
First Name & Middle Initial & Last Name & Degree
Margot Vloka, MD
First Name & Middle Initial & Last Name & Degree
Benedict Taylor, MD
Facility Name
Kansas City Cardiac Arrhythmia Research LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donita Atkins
Email
donita.atkins@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, M.D.
First Name & Middle Initial & Last Name & Degree
Ahmed Romeya, M.D.
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Liddell
Phone
507-255-8717
Email
liddell.brian@mayo.edu
First Name & Middle Initial & Last Name & Degree
Joseph Abdel Messih
Email
mansour.joseph@mayo.edu
First Name & Middle Initial & Last Name & Degree
Arman Arghami, MD
First Name & Middle Initial & Last Name & Degree
Ammar Killu, MD
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keishia Rodriguez
Email
kyrodrig@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Patrick Whalen, MD
First Name & Middle Initial & Last Name & Degree
Prashant Bhave, MD
Facility Name
TriHealth, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Henderson
Phone
513-246-1969
Email
lisa_henderson@trihealth.com
First Name & Middle Initial & Last Name & Degree
Gaurang Gandhi, MD
First Name & Middle Initial & Last Name & Degree
Eric Okum, MD
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Voorhorst
Phone
513-585-1777
Email
anne.voorhorst@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
J Michael Smith, MD
First Name & Middle Initial & Last Name & Degree
Daniel Pelchovitz, MD
Facility Name
Intermountain Healthcare
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malcolm Edwards
Email
malcolm.edwards@imail.org
First Name & Middle Initial & Last Name & Degree
Lindsey Bevan
Phone
801.507.4889
Email
lindsey.bevan@imail.org
First Name & Middle Initial & Last Name & Degree
Michael Cutler, MD
First Name & Middle Initial & Last Name & Degree
Brian Crandall, MD
First Name & Middle Initial & Last Name & Degree
Peter Smit, MD
First Name & Middle Initial & Last Name & Degree
John Doty, MD
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Kaufmann
Phone
804-828-9678
Email
abigail.kaufmann@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Vigneshwar Kasirajan, MD
First Name & Middle Initial & Last Name & Degree
Jayanthi Koneru, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Ellenbogen, MD
First Name & Middle Initial & Last Name & Degree
Arturo Cardounel, MD
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Petgrave
Phone
206-215-6573
Email
Caroline.Petgrave@Swedish.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Borchard
Email
elizabeth.borchard@swedish.org
First Name & Middle Initial & Last Name & Degree
Eric Lehr, MD
First Name & Middle Initial & Last Name & Degree
Darryl Wells, MD
Facility Name
UZ Brussels
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Roelandt
Email
brian.roelandt@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Aurélie Dubois
Email
aurelie.dubois@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Mark La Meir
First Name & Middle Initial & Last Name & Degree
Carlo de Asmundis
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29931244
Citation
Olshansky B, Sullivan RM. Inappropriate sinus tachycardia. Europace. 2019 Feb 1;21(2):194-207. doi: 10.1093/europace/euy128.
Results Reference
background
PubMed Identifier
26310298
Citation
Pellegrini CN, Scheinman MM. Epidemiology and definition of inappropriate sinus tachycardia. J Interv Card Electrophysiol. 2016 Jun;46(1):29-32. doi: 10.1007/s10840-015-0039-8. Epub 2015 Aug 27.
Results Reference
background
PubMed Identifier
31077661
Citation
Khiabani AJ, Greenberg JW, Hansalia VH, Schuessler RB, Melby SJ, Damiano RJ Jr. Late Outcomes of Surgical Ablation for Inappropriate Sinus Tachycardia. Ann Thorac Surg. 2019 Oct;108(4):1162-1168. doi: 10.1016/j.athoracsur.2019.03.103. Epub 2019 May 8.
Results Reference
background
PubMed Identifier
31084999
Citation
de Asmundis C, Chierchia GB, Sieira J, Stroker E, Umbrain V, Poelaert J, Brugada P, La Meir M. Sinus Node Sparing Novel Hybrid Approach for Treatment of Inappropriate Sinus Tachycardia/Postural Orthostatic Sinus Tachycardia With New Electrophysiological Finding. Am J Cardiol. 2019 Jul 15;124(2):224-232. doi: 10.1016/j.amjcard.2019.04.019. Epub 2019 Apr 23.
Results Reference
background
PubMed Identifier
25980576
Citation
Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.
Results Reference
background
PubMed Identifier
24721800
Citation
Nwazue VC, Paranjape SY, Black BK, Biaggioni I, Diedrich A, Dupont WD, Robertson D, Raj SR. Postural tachycardia syndrome and inappropriate sinus tachycardia: role of autonomic modulation and sinus node automaticity. J Am Heart Assoc. 2014 Apr 10;3(2):e000700. doi: 10.1161/JAHA.113.000700.
Results Reference
background
PubMed Identifier
28250298
Citation
Masumoto A, Takemoto M, Mito T, Tanaka A, Kawano Y, Kumeda H, Kang H, Matsuo A, Hida S, Okazaki T, Tayama KI, Yoshitake K, Kosuga K. Inappropriate Sinus Tachycardia Diagnosed and Treated as Depression Successfully Treated by Radiofrequency Catheter Ablation. Intern Med. 2017;56(5):523-526. doi: 10.2169/internalmedicine.56.7579. Epub 2017 Mar 1.
Results Reference
background
PubMed Identifier
32479576
Citation
Yasin OZ, Vaidya VR, Chacko SR, Asirvatham SJ. Inappropriate Sinus Tachycardia: Current Challenges and Future Directions. J Innov Card Rhythm Manag. 2018 Jul 15;9(7):3239-3243. doi: 10.19102/icrm.2018.090706. eCollection 2018 Jul. No abstract available.
Results Reference
background
PubMed Identifier
22981555
Citation
Cappato R, Castelvecchio S, Ricci C, Bianco E, Vitali-Serdoz L, Gnecchi-Ruscone T, Pittalis M, De Ambroggi L, Baruscotti M, Gaeta M, Furlanello F, Di Francesco D, Lupo PP. Clinical efficacy of ivabradine in patients with inappropriate sinus tachycardia: a prospective, randomized, placebo-controlled, double-blind, crossover evaluation. J Am Coll Cardiol. 2012 Oct 9;60(15):1323-9. doi: 10.1016/j.jacc.2012.06.031. Epub 2012 Sep 12.
Results Reference
background
PubMed Identifier
16077449
Citation
Kreisel D, Bailey M, Lindsay BD, Damiano RJ Jr. A minimally invasive surgical treatment for inappropriate sinus tachycardia. J Thorac Cardiovasc Surg. 2005 Aug;130(2):598-9. doi: 10.1016/j.jtcvs.2004.12.026. No abstract available.
Results Reference
background
PubMed Identifier
34424446
Citation
de Asmundis C, Chierchia GB, Lakkireddy D, Romeya A, Okum E, Gandhi G, Sieira J, Vloka M, Jones SD, Shah H, Winner M, Patel D, Whalen SP, Beaty EH, Kincaid EH, Lee A, Brodt C, Taylor BJ, Colombowala I, Romano M, Morady F, Stroker E, Overeinder I, Bala G, Van Meeteren J, Krauthammer Y, Koerber S, Shults C, Thomaides A, Badhwar N, Gopinathannair R, Shah A, Tummala R, Bello D, Hoff S, Almorad A, Frazier K, Brugada P, La Meir M. Sinus node sparing novel hybrid approach for treatment of inappropriate sinus tachycardia/postural sinus tachycardia: multicenter experience. J Interv Card Electrophysiol. 2022 Apr;63(3):531-544. doi: 10.1007/s10840-021-01044-5. Epub 2021 Aug 23.
Results Reference
background
Citation
C. De Asmundis et al, "Thoracoscopic Ablation of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome." Hands-On-Ablation, The Expert's Approach, Third Edition.
Results Reference
background
PubMed Identifier
34339847
Citation
Lakkireddy D, Garg J, DeAsmundis C, LaMeier M, Romeya A, Vanmeetren J, Park P, Tummala R, Koerber S, Vasamreddy C, Shah A, Shivamurthy P, Frazier K, Awasthi Y, Chierchia GB, Atkins D, Bommana S, Di Biase L, Al-Ahmad A, Natale A, Gopinathannair R. Sinus Node Sparing Hybrid Thoracoscopic Ablation Outcomes in Patients with Inappropriate Sinus Tachycardia (SUSRUTA-IST) Registry. Heart Rhythm. 2022 Jan;19(1):30-38. doi: 10.1016/j.hrthm.2021.07.010. Epub 2021 Jul 30.
Results Reference
background
PubMed Identifier
28506916
Citation
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.
Results Reference
background
PubMed Identifier
24697532
Citation
Broglio KR, Connor JT, Berry SM. Not too big, not too small: a goldilocks approach to sample size selection. J Biopharm Stat. 2014;24(3):685-705. doi: 10.1080/10543406.2014.888569.
Results Reference
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