Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Heart Failure, Unspecified Clinical Trial

Official title:

Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03001141
• Other study ID #: U1111-1190-5280
• Status: Terminated
• Start date: May 18, 2017
• Est. completion date: February 8, 2019

Study information

• Verified date: September 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Unspecified

Intervention

Other:
• Observational
Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Brazil, 

Outcome

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