Table 2

Assignment to predefined therapy according to the ILR findings

ILR findings in Phase 1ISSUE classificationTherapyPhase 2
ECG documentation of non-syncopal (asymptomatic or pre-syncopal) asystolic events of ≥ 6 sType 1PacemakerRCT
Syncope, asystolicType 1PacemakerRCT
Syncope, bradycardiaType 2CPMPC 2 study
Syncope, slight or no rhythm variationsType 3CPMPC 2 study
Syncope, sinus tachycardiaType 4ACPMPC 2 study
Syncope, tachycardiaType 4B,C,DIndividualNoa
ILR findings in Phase 1ISSUE classificationTherapyPhase 2
ECG documentation of non-syncopal (asymptomatic or pre-syncopal) asystolic events of ≥ 6 sType 1PacemakerRCT
Syncope, asystolicType 1PacemakerRCT
Syncope, bradycardiaType 2CPMPC 2 study
Syncope, slight or no rhythm variationsType 3CPMPC 2 study
Syncope, sinus tachycardiaType 4ACPMPC 2 study
Syncope, tachycardiaType 4B,C,DIndividualNoa

RCT, randomized controlled trial; CPM, counterpressure manoeuvres.

aUsual clinical management outside the trial.

Table 2

Assignment to predefined therapy according to the ILR findings

ILR findings in Phase 1ISSUE classificationTherapyPhase 2
ECG documentation of non-syncopal (asymptomatic or pre-syncopal) asystolic events of ≥ 6 sType 1PacemakerRCT
Syncope, asystolicType 1PacemakerRCT
Syncope, bradycardiaType 2CPMPC 2 study
Syncope, slight or no rhythm variationsType 3CPMPC 2 study
Syncope, sinus tachycardiaType 4ACPMPC 2 study
Syncope, tachycardiaType 4B,C,DIndividualNoa
ILR findings in Phase 1ISSUE classificationTherapyPhase 2
ECG documentation of non-syncopal (asymptomatic or pre-syncopal) asystolic events of ≥ 6 sType 1PacemakerRCT
Syncope, asystolicType 1PacemakerRCT
Syncope, bradycardiaType 2CPMPC 2 study
Syncope, slight or no rhythm variationsType 3CPMPC 2 study
Syncope, sinus tachycardiaType 4ACPMPC 2 study
Syncope, tachycardiaType 4B,C,DIndividualNoa

RCT, randomized controlled trial; CPM, counterpressure manoeuvres.

aUsual clinical management outside the trial.

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