Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure, Unspecified
- Sponsor
- Abbott Medical Devices
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Cardiac resynchronization therapy response rate measured by Clinical Composite Score
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers.
Detailed Description
Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study. Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient willing and able to sign Informed Consent Form
- •Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability
Exclusion Criteria
- •Is likely to undergo a heart transplantation within 12 months
- •Is less than 18 years old
- •Is pregnant or is planning to get pregnant during the study
- •Is currently taking part in a Clinical Trial with an active treatment group
- •Life expectancy is under 6 months
Outcomes
Primary Outcomes
Cardiac resynchronization therapy response rate measured by Clinical Composite Score
Time Frame: 12 months
Evaluated on regular medical visits and registered in the CRF
Secondary Outcomes
- Quality of Life changes, measured by MLWHF questionnaire(12 months)
- Quality of Life changes, measured by EQ-5D questionnaire(12 months)
- Change in left ventricular ejection fraction(12 months)
- Change in left ventricular end systolic volume(12 months)
- Programming strategy used (vector and intervals), obtained from the Device Session records(12 months)
- Heart failure hospitalization rate(12 months)
- All-cause mortality(12 months)