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Table 2 Secondary endpoints of the Pilot-CRAfT trial

From: Comparison of the rhythm control treatment strategy versus the rate control strategy in patients with permanent or long-standing persistent atrial fibrillation and heart failure treated with cardiac resynchronization therapy - a pilot study of Cardiac Resynchronization in Atrial Fibrillation Trial (Pilot-CRAfT): study protocol for a randomized controlled trial

 

Secondary endpoints:

BiVp%:

•

BiVp% change from baseline.

Physical competence:

•

6MWT distance

•

Peak oxygen uptake (peak VO2) in CPX

•

NYHA functional class

The echocardiographic assessment of the reverse remodelling:

•

Increase in left ventricle ejection fraction (LVEF)

•

Decrease in left ventricle diastolic diameter and volume (LVEDD, LVEDV)

•

Decrease in left ventricle systolic diameter and volume (LVESD, LVESV),

•

Decrease in size of the left atrium (LA)

•

Decrease of the severity of mitral insufficiency

Quality of life:

•

Measured with the Minnesota Living with Heart Failure Questionnaire

Clinical endpoints:

•

Unplanned hospitalizations due to heart failure exacerbations

•

Death

•

Cardiovascular death

•

Hospitalizations due to cardiovascular causes

•

Stroke/TIA

•

A combined endpoint including unplanned hospitalizations due to cardiovascular causes or death

Heart arrhythmias:

•

AF - using mode switch to measure time of AF with fast ventricular rate

•

Ventricular tachycardia including torsade de pointes tachycardia and ventricular fibrillation

In the CRT-D subgroup:

•

Number of adequate and inadequate shocks (separately)

•

The prevalence of electrical storm

Adverse events:

•

Pharmacotherapy related

•

Device related

•

Cardioversion related

•

AVJA related

  1. The clinical endpoints, the occurrence of heart arrhythmias and adverse events are collected for safety measures. All of the endpoints will be assessed at three-months and one-year from the baseline timeframes.
  2. 6MWT, six-minute walk test; AF, atrial fibrillation; AVJA, atrioventricular junction ablation; BiVp%, effectively biventricular paced captured beats percentage; CPX, cardiopulmonary exercise test; CRT-D, cardiac resynchronization therapy with defibrillator function; TIA, transient ischemic attack.