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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03546374
Other study ID # MDT17066ECT001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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