Clinical Studies

Question 1

What did the SAVE-PACE Trial demonstrate?

Answer 1

• minimizing RV pacing led to a 40% reduction in risk of developing persistent AF
• the reduced risk led to fewer invasive procedures and HFH

Question 2

What did the DAVID trial demonstrate?

Answer 2

RV pacing >40% increased risk of HFH and death in patients with intact conduction

Question 3

What did the MOST Sub-Study demonstrate?

Answer 3

• looked at cumulative effect of VPacing
• risk of HFH increased 5.4% for every 1% VP up to 40%
• risk of AF in patients with SND increases linearly 1% for every 1% VP up to 85%

Question 4

What did the DANISH II Trial demonstrate?

Answer 4

• long term DDDR pacing causes LA dilation
• high RV pacing decreases LV function
• AAIR pacing reduces AF risk

Question 5

The PainFree I & II trials showed that ATP successfully terminated ______ fast VT epidsodes?

Answer 5

3 out of 4

Question 6

The PainFree I & II trials showed that what percentage of VF was actually fast VT?

Answer 6

76%

Question 7

What was the final result demonstrated by the PainFree I & II trials?

Answer 7

that ATP was safe and effective for patients implanted with an ICD for secondary prevention or after experiencing an MI

Question 8

Which trial(s) demonstrated that ATP was safe and effective for ICD patients?

Answer 8

the PainFree I & II trials

Question 9

Which clinical trial confirmed the safety and efficacy of ATP in all ICD indicated patients as well as the results of the PainFree I & II trials?

Answer 9

ADVANCE D trial

Question 10

What was the focus of the EnTrust clinical trial?

Answer 10

studied ATP during charging

Question 11

What did the EnTrust clinical trial show?

Answer 11

• ATP during charging terminated 69% of Fast VT with a low risk of acceleration or symptoms
• no difference in time of first shock compare to no ATO