Degenerative Mitral Regurgitation in Intermediate Risk Patients

NCT02604745 | Completed

• 1 other identifier: STU00201771
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.

Conditions

Mitral Valve Insufficiency; Mitral Regurgitation

Keywords

degenerative mitral regurgitation

Outcome Measures

Primary Outcomes (1)

• Exercise Capacity

  To evaluate exercise duration and workload (METS) in patients who have undergone mitral valve surgery for degenerative mitral regurgitation

  6 to 36 months Post Index Procedure

Secondary Outcomes (2)

• Change in HRQOL

  Baseline (Index procedure) up to 36 months after surgery

• Change in mitral regurgitation

  Pre-procedure up to 36 months after surgery

Study Arms (1)

Degenerative Mitral Regurgitation

This cohort includes patients that have had mitral valve surgery for Degenerative Mitral Regurgitation (Type II)

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of mitral valve surgery for Degenerative Mitral Regurgitation (Type II).

You may qualify if:

• Prior surgery for degenerative mitral regurgitation (DMR) at Northwestern Memorial Hospital performed by a single surgeon.
• Male and female ≥ 65 years of age at time of index procedure.
• Mitral Valve surgery performed \> 6 months and \<36 months at the time of consent. Concomitant procedures at time of index procedure may include incidental CAB, MAZE and tricuspid valve surgery.
• STS (Society of Thoracic Surgeons) mortality risk score of ≥ 2 and \< 6 for mitral valve repair or ≥ 2 and \< 8 for mitral valve replacement at time of index procedure.
• Able to speak, read, and understand English

You may not qualify if:

• Pre-operative tricuspid regurgitation of 4+ (severe) at time of index procedure.
• Severe RV Dysfunction.
• Contraindication to exercise testing (i.e., Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, etc.).
• Unable to perform an exercise test due to clinical criteria such oxygen dependency, neuromuscular limitations, NYHA class 4, unstable angina, and postural hypotension.
• Surgical or interventional cardiac procedure or other intervention since the index procedure that in the opinion of the Investigator may confound data analysis.
• Left ventricular ejection fraction \<30%.
• Subjects unwilling or unable to give written informed consent.

Sponsors & Collaborators

• Northwestern University: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Patrick M McCarthy, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cardiac Surgery

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 13, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

US (1)