Study for the Treatment of Heart Failure With Preserved Ejection Fraction Associated With High Blood Pressure Using Right Atrial Pacing Controlled by the PressurePaceTM System

Korábbi kezelés

• Indications for emergency surgery at time of screening or planned surgery before the 49-day follow-up
• Hospitalized in the prior six months for a heart attack, stroke, or TIA, or have a history of blood-pressure related syncope in last 6 months.

Más betegség

• Physical or psychological condition which would impair study participation.
• End Stage Renal Disease on haemodialysis
• Prone to atrial or ventricular arrhythmias with altered pacing.
• Unstable from a cardiovascular standpoint, such as on-going chest pain, the diagnosis of heart failure with reduced EF, or who report being ill or otherwise uncomfortable, medically, or psychologically at the time of study.

Egyéb

• A resting SBP > 170 mmHg, or < 130 SBP at screening average over 3 readings in 30 minutes. The readings will be taken with the blood pressure cuff on the subject's left arm while seated after at least ten minutes of rest. Consecutive readings will be taken at least 10 minutes apart.
• A resting DBP > 120 mmHg, or < 80 at screening average over 3 measurements in 30 minutes.
• Pregnant or breast-feeding.
• Have a pacemaker that is currently the subject of a manufacturer's recall or regulatory advisory of malfunction.
• Unable to interact and execute commands with the BaroPace modules during the screening phase.
• Taking short acting Nifedipine or Clonidine or taking ISA Beta Blockers; Acebutolol, Pindolol, Sectral or Visken

• Have a Pacetronix dual chamber pacemaker implanted for > 2 weeks that is more than 6 months from ERI (elective replacement indicator).
• Ages: Adult subjects > 35 years and < 90 of age.
• Have heart failure with preserved ejection fraction defined as ejection fraction > 45 percent.
• Have hypertension (SBP >135 mmHg) within 30 days before the start of screening, despite at least one or more medication for the treatment of hypertension.
• Screening average right atrial pacing < 50% and average intrinsic/pacing heart rate < 70 bpm over the previous clinical monitoring period of the pacemaker diagnostics of at least 14 days
• Blood pressure of no less than 135 systolic and a diastolic blood pressure no less than 85 mm Hg at initial screening over 3 readings in 30 minutes in the sitting position, in the left arm.
• Able to tolerate at least 3 minutes of a Modified Bruce Protocol Treadmill
• Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and a baseline distance of at least 225 meters. Symptoms limiting the duration of the 6-minute walk test must be due to heart failure alone.
• Willing and able to sign consent.
• Stable medications for Hypertension for at least 4 weeks prior to screening.