Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent (CURE-AF/Perst)

November 27, 2023 updated by: Medtronic Cardiac Surgery

Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Persistent Study

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat persistent AF patients.

Study Overview

Status

Completed

Conditions

Atrial Fibrillation

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Phoenix, Arizona, United States, 85260
    - Southwest Heart and Lung
- California
  - Concord, California, United States, 94520
    - East Bay Cardiovascular & Thoracic Associates
  - Los Angeles, California, United States, 90033
    - University of Southern California
  - Palm Springs, California, United States, 92270
    - Eisenhower Medical Center
- Florida
  - Saint Petersburg, Florida, United States, 33701
    - Cardiac Surgical Associates of Florida
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital
- Minnesota
  - Rochester, Minnesota, United States, 55902
    - Mayo/St. Mary's Hospital
- Missouri
  - Saint Louis, Missouri, United States, 63310
    - Washington University School of Medicine
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - New Mexico Heart Institute
- New York
  - New York, New York, United States, 10075
    - Lenox Hill Hospital
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Hospital of University of Pennsylvania
- Virginia
  - Falls Church, Virginia, United States, 22042
    - Inova Fairfax
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53515
    - Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: Characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days.
Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
- Mitral valve repair or replacement
- Aortic valve repair or replacement
- Tricuspid valve repair or replacement
- Atrial septal defect (ASD) repair
- Patent foramen ovale (PFO) closure
- Coronary artery bypass procedures
Greater than or equal to 18 years of age
Able and willing to comply with study requirements by signing a consent form
Must be able to take the anticoagulant warfarin (Coumadin)

Exclusion Criteria:

Wolff-Parkinson-White syndrome
NYHA Class = IV
Left ventricular ejection fraction ≤ 30%
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Previous atrial ablation for AF, AV-nodal ablation, or surgical Maze procedure
Contraindication for anticoagulation therapy
Left atrial diameter > 7.0 cm
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Life expectancy of less than one year
Pregnancy or desire to be pregnant within 12 months of the study treatment.
Current diagnosis of active systemic infection
Documented MI 6 weeks prior to study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months Time Frame: 9 months	Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours	9 months
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge Time Frame: 30 days post procedure or hospital discharge	Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.	30 days post procedure or hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months Time Frame: 9 months		9 months
Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure Time Frame: 9 months	Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.	9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Surgery

Investigators

Principal Investigator: Thoralf Sundt, MD, The Mayo Clinic- Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 22, 2007

First Submitted That Met QC Criteria