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ACTIVE NOT RECRUITING NA

MitraClip REPAIR MR Study

NCT04198870 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Conditions Studied

Interventions

  • DEVICE MitraClip™ device implantation
  • PROCEDURE Mitral Valve Repair Surgery

Study Locations (20)

California

  • Scripps Health — La Jolla
  • Sutter Medical Center, Sacramento — Sacramento
  • University of California - Davis Medical Center — Sacramento
  • Mercy General Hospital — Sacramento
  • University of California at San Francisco — San Francisco
  • Stanford University Medical Center — Stanford
  • Los Robles Regional Medical Center — Thousand Oaks

Arizona

  • Banner-University Medical Center Phoenix — Phoenix
  • St. Josephs Hospital and Medical Center — Phoenix
  • Arizona Cardiovascular Research Center — Phoenix
  • Tucson Medical Center — Tucson

Alabama

  • University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham
  • Cardiology Associates of Mobile, Inc. — Mobile

Florida

  • Baptist Medical Center — Jacksonville
  • NCH Healthcare System — Naples

Illinois

  • Northwestern Memorial Hospital — Chicago
  • Prairie Education & Research Cooperative — Springfield

Colorado

  • Saint Joseph Hospital — Denver

Connecticut

  • Yale New Haven Hospital — New Haven

Georgia

  • Piedmont Heart Institute — Atlanta

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2020-07-21
Est. Completion 2035-12
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04198870

The ClinicalTrials.gov registry entry for NCT04198870 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Mitral Valve Regurgitation appearing as the primary indexed condition, and to 2 interventions — of which MitraClip™ device implantation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04198870 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04198870 about?

NCT04198870 is a clinical study titled "MitraClip REPAIR MR Study". The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by...

What is the current status of trial NCT04198870?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2020-07-21. Estimated completion is 2035-12.

What conditions does trial NCT04198870 study?

This clinical trial studies the following conditions: Mitral Valve Regurgitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04198870?

The interventions under investigation include: MitraClip™ device implantation (DEVICE), Mitral Valve Repair Surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04198870?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04198870 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial