Table 2.
Effectiveness and safety endpoints
| Primary effectiveness endpoint | Freedom from IST defined as mean heart rate of ≤90 beats/min or at least a 15% reduction in mean heart rate as compared with baseline, in the absence of new or higher dosage of previously failed medications. |
| Secondary effectiveness endpoints | Change in 6-MWT from baseline compared with 6, 12, and 24 mo postprocedure. |
| Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared with 6, 12, and 24 mo postprocedure. The Borg dyspnea score will be assessed at each of the 6-MWT. | |
| Change from baseline in psychological evaluation compared with 6, 12, and 24 mo postprocedure utilizing the SAS. | |
| IST symptom reduction at baseline and 6, 12, and 24 mo postprocedure. | |
| Change in QoL based on a SF-12 domain and component scores at baseline compared with 6, 12, and 24 mo postprocedure. | |
| Change in mean heart rate at 6, 12, and 24 mo postprocedure compared with baseline, using 7-d continuous monitoring. | |
| Freedom from IST or at least 15% reduction in mean heart rate at 12 and 24 mo compared with baseline, in the absence of rate control drugs (beta-blockers/calcium-channel blockers, ivabradine) and/or AADs. | |
| Freedom from IST or at least a 15% reduction in mean heart rate at 12 and 24 mo compared with baseline, regardless of rate control drugs (beta-blockers/calcium-channel blockers, ivabradine) and/or AADs. | |
| Device- or procedure-related SAEs through 12 mo. | |
| Improved heart rate variability for subjects using 7-d continuous monitoring. | |
| Improved heart rate variability and activity levels for subjects with ILRs. | |
| Health economics: emergency room visits and readmission. | |
| Primary safety endpoint | Pericardial effusions with cardiac tamponade requiring surgical intervention.∗ |
| Cardiovascular injury requiring surgical intervention.∗ | |
| Excessive bleeding requiring reoperation or 2 or more units of PBRC transfusion or results in ≥20% decrease in hematocrit within 30 d of the index procedure.∗ | |
| Pericarditis requiring surgical treatment (ie, pericardiotomy).∗ | |
| Permanent pacemaker implantation (eg, due to lack of sinus node recovery or bradycardia <40 beats/min).∗ | |
| New atrial arrhythmia as a result of the hybrid ablation procedure, requiring intervention.∗ | |
| Infection at the surgical site requiring reoperation.∗ | |
| Permanent diaphragmatic paralysis.† |
6-MWT = 6-minute walk test; AAD = antiarrhythmic drug; ILR = implantable loop recorder; IST = inappropriate sinus tachycardia; MAE = major adverse event; PRBC = packed red blood cell; QoL = quality of life; SAE = serious adverse event; SAS = Self-Rating Anxiety Scale; SF-12 = 12-item Short Form Survey.
∗
These MAEs occurring within 30 days of the ablation procedure will contribute toward the primary safety endpoint.
†
This MAE occurring after 30 days of the procedure and lasting for 12 months will also contribute toward the primary safety endpoint.