Clinical trial NCT03546374: Medtronic Terminate AF Study
Official title: Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite acute major adverse event rate
timeFrame: 30-days post-procedure or hospital discharge (whichever is longer)
measure: Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
timeFrame: 6-months post-procedure to 12-months post-procedure
Secondary outcomes:
measure: Composite acute major adverse event rate (Safety)
timeFrame: 6-months post-procedure
measure: Composite acute major adverse event rate (Safety)
timeFrame: 12-months post-procedure
measure: Percentage of new permanent pacemaker implantation (Safety)
timeFrame: 12-months post-procedure
measure: Acute procedural success (Efficacy)
timeFrame: During index procedure
measure: Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)
timeFrame: 6-months post-procedure
measure: Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)
timeFrame: 6-months post-procedure
measure: Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)
timeFrame: 12-months post-procedure
measure: AFEQT Quality of Life Score over time (Efficacy)
timeFrame: 12-months post-procedure
measure: SF-12 Quality of Life Score over time (Efficacy)
timeFrame: 12-months post-procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospitals and Clinic
state: California
city: Saint Helena
country: United States
facility: Adventist Health St. Helena
state: California
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Indianapolis
country: United States
facility: St Vincent Heart Center of Indiana
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Toledo
country: United States
facility: ProMedica Toledo
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Heart Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: St. Joseph Medical Center
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Ralph J Damiano, MD
role: PRINCIPAL_INVESTIGATOR
References: