Heart Failure, Unspecified
Conditions
Keywords
MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, Quadripolar pacing
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.
Interventions
OTHERObservational
Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac resynchronization therapy response rate measured by Clinical Composite Score | 12 months | Evaluated on regular medical visits and registered in the CRF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life changes, measured by EQ-5D questionnaire | 12 months | Evaluated on regular medical visits and registered in the CRF |
| Change in left ventricular ejection fraction | 12 months | Evaluated on regular medical visits and registered in the CRF |
| Change in left ventricular end systolic volume | 12 months | Evaluated on regular medical visits and registered in the CRF |
| Quality of Life changes, measured by MLWHF questionnaire | 12 months | Evaluated on regular medical visits and registered in the CRF |
| Heart failure hospitalization rate | 12 months | Evaluated on regular medical visits and registered in the CRF |
| All-cause mortality | 12 months | Evaluated on regular medical visits and registered in the CRF |
| Programming strategy used (vector and intervals), obtained from the Device Session records | 12 months | Evaluated on regular medical visits and registered in the CRF |
Countries
Brazil
Outcome results
None listed