User Manual Part 4

D-32

CLINICAL STU DY - CONTAK CD

•Age≥ 18 years

• Optimal pharmacologic therapy for heart failure

• Abletowalkbetween150and425minaSix-MinuteWalktest

Major Diffe re nces Between CONTA K CD and Focused Conﬁrmatory

Study Patients

The CON TA K RENEWAL 3, CONTAK RENEWAL, and CONTAK CD devices

provide the same cardiac resynchronization therapy (biventricular pacing) and

have the same Indications for Use. Therefore, the CONTAK CD clinical trial

data used to support CONTAK CD is also applicable to CONTAK RENEWAL

and CONTAK RENEWAL 3. The primary difference between CONTAK CD

devices and CONTAK RENEWAL and CONTAK RENEWAL 3 devices is that

CONTAK CD utilizes an electrically common RV and LV sensing/pacing circuit

whereas CONTAK RENEWAL and CONTAK RENEWAL 3 incorporate an

independent RV and LV sensing/pacing circuit. Additional clinical analysis

was also conducted with CONTA K RENEWAL to provide conﬁrmation that the

independe nt sens ing and pacing capa bility did not adversely affect the ability

of the device to detect ventricular tachyarrhythmias or provide continuous

biventricular pacing therapy.

Some of the major differences between the study populations included:

• Patients were excluded from the FCS if they were indicated for either

a pacemaker or implantable cardioverter deﬁbrillator (ICD). Pa tients in

the CONTAK CD Study were excluded if they met the indications for a

pacemaker; however, they were required to meet the general indications

for a n ICD.

• Patients were excluded from the FCS if they were hospitalized for heart

failure in the month prior to enrollment; wherea s, there was no exclusion

for hospitalization for heart failure in the month prior to enrollment for the

CONTAK CD patients.

• Patients in the FCS must have been on stable, optimal heart failure

medications, including beta blocker therapy for three months, prior to study

entry. Patients in the CONTAK CD Study could be optimized on drug

therapy between t he t ime from device implant u nt il the tre at ment phase

(either CRT or No CRT) began.

- DRAFT -