Heart Failure, Unspecified Clinical Trial
Official title:
Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
Verified date | September 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 200 |
Est. completion date | February 8, 2019 |
Est. primary completion date | April 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinica Dom Rodrigo | João Pessoa | PB |
Brazil | BP | São Paulo | SP |
Brazil | Instituto de Arritmias Cardíacas | São Paulo | SP |
Brazil | SEMAP | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac resynchronization therapy response rate measured by Clinical Composite Score | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | Quality of Life changes, measured by MLWHF questionnaire | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | Quality of Life changes, measured by EQ-5D questionnaire | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | Change in left ventricular ejection fraction | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | Change in left ventricular end systolic volume | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | Programming strategy used (vector and intervals), obtained from the Device Session records | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | Heart failure hospitalization rate | Evaluated on regular medical visits and registered in the CRF | 12 months | |
Secondary | All-cause mortality | Evaluated on regular medical visits and registered in the CRF | 12 months |