MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

Official title:

MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982979
• Other study ID #: ABT-CIP-10273
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: September 8, 2021

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial. A total of 1028 subjects were enrolled in the MOMENTUM 3 IDE trial. Approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this PAS. This study will be conducted at sites that participated in the MOMENTUM 3 IDE trial which will include up to 69 centers in the United States.

Description:

Subjects on LVAD support after the MOMENTUM 3 IDE trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. They will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first. Subjects who have been transplanted, their device exchanged to another pump other than a HM II or HM3, or explanted after the MOMENTUM 3 IDE trial 2-year follow-up but prior to providing consent for this PAS can also be enrolled. Data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected. Once enrolled, if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed. In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject or legal representative has signed Informed Consent Form (ICF)
• Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit

Exclusion Criteria:

• Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit

Special Circumstance:

• Sites with patients who expired after the MOMENTUM 3 IDE trial 2-year follow-up visit but prior to signing the ICF for this PAS will obtain IRB approval to collect only the date and cause of death

Related Conditions & MeSH terms

• Advanced Refractory Left Ventricular Heart Failure
• Heart Failure

Intervention

Device:
• HM3 LVAS
HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)

Locations

Country	Name	City	State
United States	Abbott	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump	up to 5 years post-implant
Primary	Subject outcomes and survival	Subject outcomes and survival which includes death, transplant, explant, or a pump exchange to any device other than HM II or HM3	up to 5 years post-implant
Primary	Bleeding (including GI bleeding)	Frequency and incidence of bleeding (including GI bleeding)	up to 5 years post-implant
Primary	Major infection	Frequency and incidence of major infection	up to 5 years post-implant
Primary	Hemolysis	Frequency and incidence of hemolysis	up to 5 years post-implant
Primary	Device thrombosis	Frequency and incidence of device thrombosis	up to 5 years post-implant
Primary	Neurological dysfunction	Frequency and incidence of neurological dysfunction	up to 5 years post-implant
Primary	Device related SAEs	Frequency and incidence of device related SAEs	up to 5 years post-implant
Primary	NYHA	New York Heart Association (NYHA) classification	up to 5 years post-implant
Primary	6MWD	Six-minute walk distance (6MWD)	up to 5 years post-implant