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Medtronic Terminate AF Study

Primary Purpose

Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical Ablation
Cardioblate and Cryoflex hand held devices
Sponsored by
Medtronic Cardiac Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of non-paroxysmal AF (persistent or longstanding persistent)

  2. Concomitant indication for non-emergent open-heart surgery, eg,

    1. Coronary artery bypass grafting
    2. Valve repair or replacement
  3. Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Exclusion Criteria:

  • Wolff-Parkinson-White syndrome
  • NYHA Class = IV
  • Left Ventricular Ejection Fraction ≤ 30%
  • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  • Previous AF ablation, AV-nodal ablation, or surgical Maze procedure
  • Contraindication for anticoagulation therapy
  • Left atrial diameter > 6.0 cm
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Renal failure requiring dialysis or hepatic failure
  • Life expectancy of less than 1 year
  • Predicted risk of operative mortality >10% as assessed by STS Risk Calculator
  • Pregnancy or desire to be pregnant within 12 months of the study treatment
  • Current diagnosis of active systemic infection
  • Active endocarditis
  • Documented MI 30 days prior to study enrollment
  • Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Sites / Locations

  • Stanford Hospitals and ClinicRecruiting
  • Adventist Health St. HelenaRecruiting
  • Hartford HealthcareRecruiting
  • St Vincent Heart Center of IndianaRecruiting
  • Massachusetts General HospitalRecruiting
  • Spectrum Health HospitalsRecruiting
  • Washington University School of MedicineRecruiting
  • ProMedica ToledoRecruiting
  • Allegheny General HospitalRecruiting
  • Lankenau Medical CenterRecruiting
  • Intermountain Medical CenterRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Virginia Mason Heart InstituteRecruiting
  • Swedish Medical CenterRecruiting
  • St. Joseph Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Cohort

Arm Description

Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery

Outcomes

Primary Outcome Measures

Composite acute major adverse event rate
Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.
Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.

Secondary Outcome Measures

Composite acute major adverse event rate (Safety)
Composite acute major adverse event rate at 6 months post-procedure (as defined above)
Composite acute major adverse event rate (Safety)
Composite acute major adverse event rate at 12 months post-procedure (as defined above)
Percentage of new permanent pacemaker implantation (Safety)
Percentage of new permanent pacemaker implantation presented by indication
Acute procedural success (Efficacy)
Acute procedural success (pulmonary vein isolation)
Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)
Freedom from AF/AFL/AT of 30 seconds or greater duration after removal from AAD therapy as assessed from the end of the 3-month blanking period through 6 months post-procedure
Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)
Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure
Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)
Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure
AFEQT Quality of Life Score over time (Efficacy)
Characterization of quality of life scores over time as assessed by AFEQT questionnaire. AFEQT overall score ranges from 0-100. Zero corresponds to complete disability and 100 corresponds to no disability. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval.
SF-12 Quality of Life Score over time (Efficacy)
Characterization of quality of life scores over time as assessed by SF-12 questionnaire. SF-12 overall score ranges from 0-100. Zero indicates the lowest level of health measured by the scale and 100 indicates the highest level of health. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval.

Full Information

First Posted
May 9, 2018
Last Updated
October 20, 2023
Sponsor
Medtronic Cardiac Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT03546374
Brief Title
Medtronic Terminate AF Study
Official Title
Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF.
Detailed Description
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the US. The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Cohort
Arm Type
Experimental
Arm Description
Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
Intervention Type
Procedure
Intervention Name(s)
Surgical Ablation
Intervention Description
In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.
Intervention Type
Device
Intervention Name(s)
Cardioblate and Cryoflex hand held devices
Intervention Description
The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.
Primary Outcome Measure Information:
Title
Composite acute major adverse event rate
Description
Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.
Time Frame
30-days post-procedure or hospital discharge (whichever is longer)
Title
Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Description
Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.
Time Frame
6-months post-procedure to 12-months post-procedure
Secondary Outcome Measure Information:
Title
Composite acute major adverse event rate (Safety)
Description
Composite acute major adverse event rate at 6 months post-procedure (as defined above)
Time Frame
6-months post-procedure
Title
Composite acute major adverse event rate (Safety)
Description
Composite acute major adverse event rate at 12 months post-procedure (as defined above)
Time Frame
12-months post-procedure
Title
Percentage of new permanent pacemaker implantation (Safety)
Description
Percentage of new permanent pacemaker implantation presented by indication
Time Frame
12-months post-procedure
Title
Acute procedural success (Efficacy)
Description
Acute procedural success (pulmonary vein isolation)
Time Frame
During index procedure
Title
Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)
Description
Freedom from AF/AFL/AT of 30 seconds or greater duration after removal from AAD therapy as assessed from the end of the 3-month blanking period through 6 months post-procedure
Time Frame
6-months post-procedure
Title
Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)
Description
Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure
Time Frame
6-months post-procedure
Title
Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)
Description
Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure
Time Frame
12-months post-procedure
Title
AFEQT Quality of Life Score over time (Efficacy)
Description
Characterization of quality of life scores over time as assessed by AFEQT questionnaire. AFEQT overall score ranges from 0-100. Zero corresponds to complete disability and 100 corresponds to no disability. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval.
Time Frame
12-months post-procedure
Title
SF-12 Quality of Life Score over time (Efficacy)
Description
Characterization of quality of life scores over time as assessed by SF-12 questionnaire. SF-12 overall score ranges from 0-100. Zero indicates the lowest level of health measured by the scale and 100 indicates the highest level of health. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval.
Time Frame
12-months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of non-paroxysmal AF (persistent or longstanding persistent) Concomitant indication for non-emergent open-heart surgery, eg, Coronary artery bypass grafting Valve repair or replacement Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC) Exclusion Criteria: Wolff-Parkinson-White syndrome NYHA Class = IV Left Ventricular Ejection Fraction ≤ 30% Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery Previous AF ablation, AV-nodal ablation, or surgical Maze procedure Contraindication for anticoagulation therapy Left atrial diameter > 6.0 cm Preoperative need for an intra-aortic balloon pump or intravenous inotropes Renal failure requiring dialysis or hepatic failure Life expectancy of less than 1 year Predicted risk of operative mortality >10% as assessed by STS Risk Calculator Pregnancy or desire to be pregnant within 12 months of the study treatment Current diagnosis of active systemic infection Active endocarditis Documented MI 30 days prior to study enrollment Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Yong
Phone
763-526-2032
Email
stephanie.yong@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Halverson
Phone
763-514-9765
Email
Jessica.halverson@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J Damiano, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospitals and Clinic
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anson Lee, MD
Email
ansonlee@stanford.edu
Facility Name
Adventist Health St. Helena
City
Saint Helena
State/Province
California
ZIP/Postal Code
94574
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gansevoort Dunnington, MD
Email
dunningh@ah.org
Facility Name
Hartford Healthcare
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hagberg, MD
Email
Robert.Hagberg@hhchealth.org
Facility Name
St Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Heimansohn, MD
Email
heimansohn@mac.com
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serguei Melnitchouk, MD
Email
smelnitchouk@mgh.harvard.edu
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Murphy, MD
Email
edward.murphy@spectrumhealth.org
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph J Damiano, MD
Email
damianor@wustl.edu
Facility Name
ProMedica Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Moront, MD
Email
Michael.Moront@promedica.org
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Bailey, MD
Email
stephen.bailey@ahn.org
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basel Ramlawi, MD
Email
RamlawiB@mlhs.org
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Doty, MD
Email
John.Doty@imail.org
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Newton, MD
Email
jnewton@sentara.com
Facility Name
Virginia Mason Heart Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Moraca, MD
Email
Bob.Moraca@Virginiamason.org
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lehr, MD
Email
Eric.Lehr@swedish.org
Facility Name
St. Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Withdrawn

12. IPD Sharing Statement

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Medtronic Terminate AF Study

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