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. 2018 Jul 15;9(7):3221–3231. doi: 10.19102/icrm.2018.090702

Table 2:

Trials of Pacemakers for NCS

Study Type of Study Inclusion Criteria Number of Patients (Intervention/Control) Intervention/Control Mean Follow-up Syncope Recurrence (Intervention/Control)
Connolly et al. 199933 Nonblinded RCT ≥ six episodes of syncope plus HUT with relative bradycardia 54 (27/27) DDD with rate-drop response/standard treatment 1 year 22%/70% (p < 0.0001)
Sutton et al. 200034 Nonblinded RCT ≥ three episodes of syncope in two years;
VASIS IIa or IIb on HUT
42 (19/23) DDI with hysteresis/no therapy 3.7 years 5%/61% (p = 0.0006)
Ammirati et al. 200135 Nonblinded RCT ≥ three episodes of syncope in two years plus HUT with relative bradycardia 93 (46/47) DDD with rate-drop response/atenolol 520 days 4.3%/25.5% (p = 0.004)
Connolly et al. 200336 Double-blinded RCT ≥ six total episodes of syncope or ≥ three episodes in two years plus HUT with heart rate × blood pressure < 6,000 bpm × mmHg 94 (42/52) DDD with rate-drop response/sensing only (ODO) 6 months 33%/42% (p = 0.14)
Raviele et al. 200437 Double-blinded RCT ≥ six episodes of syncope plus HUT with asystolic or mixed response 29 (16/13) DDD with rate-drop response/no pacing (OOO) 715 days 50%/33% (p = not reported)
Brignole et al. 200639 Observational ≥ three episodes of syncope in two years 392 Implantable loop recorder- based specific therapy (pacemaker, anti-tachycardia therapy)/no therapy 9 months 11%/35% (p = 0.002)
Brignole et al. 201440 Double-blinded RCT ≥ three episodes of syncope in two years; ILR-documented asystolic response 77 (38/39) DDD with rate-drop response/sensing only (ODO) 2 years 25%/57% (p = 0.039)
Flammang et al. 201241 SIngle-blinded RCT Isolated or recurrent syncope; > 10-second pause on ATP test 80 (39/41) DDD/backup pacing (AAI) 16 months 66%/21% (p = not reported)

NCS: neurocardiogenic syncope; RCT: randomized controlled trial; HUT: head-up tilt test; ILR: implantable loop recorder; ATP: adenosine triphosphate.