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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
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.
Time frame: 12-months Post Procedure
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
Time frame: 30-days Post Procedure
6-Minute Walk Test
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
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.
Time frame: 24-months Post Procedure
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)
Time frame: 24-months Post Procedure
IST symptom reduction
IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure
Time frame: 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
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Loma Linda University Health
Loma Linda, California, United States
RECRUITINGSequoia Hospital
Redwood City, California, United States
RECRUITINGStanford University
Redwood City, California, United States
RECRUITINGSaint Vincent's Medical Center
Bridgeport, Connecticut, United States
RECRUITINGMedstar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGBaptist Health
Miami, Florida, United States
WITHDRAWNSarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITINGSt. Joseph's Hospital / Baycare Health System
Tampa, Florida, United States
RECRUITINGMemorial Health University Medical Center
Savannah, Georgia, United States
RECRUITING...and 16 more locations
Time frame: 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
Time frame: 24-months Post Procedure
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
Time frame: 24-months Post Procedure
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
Time frame: 24-months Post Procedure
Device or procedure related Serious Adverse Events
Device or procedure related Serious Adverse Events (SAEs) through 12-months
Time frame: 12-months Post Procedure
Improved heart rate variability - 7-day monitor
Improved heart rate variability for subjects using 7-day continuous monitoring
Time frame: 12-months Post Procedure
Improved heart rate variability - Implantable loop recorder
Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)
Time frame: 12-months Post Procedure
Health Economics
Health Economics: ER visits and readmissions
Time frame: 24-months Post Procedure