Medtronic Terminate AF Study

Persistent Atrial Fibrillation Clinical Trial

Official title:

Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03546374
• Other study ID #: MDT17066ECT001
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Medtronic Cardiac Surgery
• Contact: Stephanie Yong
• Phone: 763-526-2032
• Email: stephanie.yong[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of non-paroxysmal AF (persistent or longstanding persistent)

• Concomitant indication for non-emergent open-heart surgery, eg,

1. Coronary artery bypass grafting

2. 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Surgical Ablation
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.

Device:
• Cardioblate and Cryoflex hand held devices
The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	Hartford Healthcare	Hartford	Connecticut
United States	St Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Intermountain Medical Center	Murray	Utah
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Stanford Hospitals and Clinic	Palo Alto	California
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Adventist Health St. Helena	Saint Helena	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Heart Institute	Seattle	Washington
United States	St. Joseph Medical Center	Tacoma	Washington
United States	ProMedica Toledo	Toledo	Ohio
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30-days post-procedure or hospital discharge (whichever is longer)
Primary	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.	6-months post-procedure to 12-months post-procedure
Secondary	Composite acute major adverse event rate (Safety)	Composite acute major adverse event rate at 6 months post-procedure (as defined above)	6-months post-procedure
Secondary	Composite acute major adverse event rate (Safety)	Composite acute major adverse event rate at 12 months post-procedure (as defined above)	12-months post-procedure
Secondary	Percentage of new permanent pacemaker implantation (Safety)	Percentage of new permanent pacemaker implantation presented by indication	12-months post-procedure
Secondary	Acute procedural success (Efficacy)	Acute procedural success (pulmonary vein isolation)	During index procedure
Secondary	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	6-months post-procedure
Secondary	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	6-months post-procedure
Secondary	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	12-months post-procedure
Secondary	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.	12-months post-procedure
Secondary	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.	12-months post-procedure