Menu
Recruiting NCT03546374

Medtronic Terminate AF Study

No phase Interventional Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical Ablation, Cardioblate and Cryoflex hand held devices.
Who it may be relevant to
Registry conditions: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 atrial fibrillation (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 United States (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.

Interventions

  • 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 Cryoflex surgical ablation devices.

Primary outcome measures

  • Composite acute major adverse event rate [Time frame: 30-days post-procedure or hospital discharge (whichever is longer)]
  • Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT) [Time frame: 6-months post-procedure to 12-months post-procedure]
Secondary outcome measures (9)
  • Composite acute major adverse event rate (Safety) [Time frame: 6-months post-procedure]
  • Composite acute major adverse event rate (Safety) [Time frame: 12-months post-procedure]
  • Percentage of new permanent pacemaker implantation (Safety) [Time frame: 12-months post-procedure]
  • Acute procedural success (Efficacy) [Time frame: During index procedure]
  • Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy) [Time frame: 6-months post-procedure]
  • Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy) [Time frame: 6-months post-procedure]
  • Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy) [Time frame: 12-months post-procedure]
  • Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Quality of Life Score over time (Efficacy) [Time frame: 12-months post-procedure]
  • SF-12 Health Survey (SF-12) Quality of Life Score over time (Efficacy) [Time frame: 12-months post-procedure]

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
  • New York Heart Association (NYHA) Class = IV
  • Left Ventricular Ejection Fraction ≤ 30%
  • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  • Previous AF ablation, atrioventricular (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 15 centers
  • Stanford Hospitals and Clinic — Palo Alto
  • Adventist Health St. Helena — St. Helena
  • Hartford Healthcare — Hartford
  • St Vincent Heart Center of Indiana — Indianapolis
  • Massachusetts General Hospital — Boston
  • Corewell Health — Grand Rapids
  • Washington University School of Medicine — St Louis
  • ProMedica Toledo — Toledo
  • … and 7 more centers

Identifiers

NCT: NCT03546374 · MDT17066ECT001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗