A(f)MAZE-CABG Study (AFMAZE-CABG)

January 31, 2019 updated by: Abbott Medical Devices

A Prospective Randomized Trial Comparing Freedom From Atrial Fibrillation at One Year Post CABG in Patients Undergoing Concomitant Left Atrial Ablation Using HIFU Versus CABG in Patients With Persistent or Long Standing Persistent AF

Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG treated with best medical treatment according to ACC/AHA/ESC 2006 guidelines and no AF ablation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Primary Objective

• To compare the efficacy of concomitant AF ablation using HIFU to no ablation at 12 months in patients with persistent or long standing persistent AF undergoing CABG according to ACC/AHA/ESC 2006 guidelines and HRS/EHRA/ECAS Consensus Statement on Catheter and Surgical Ablation .

Secondary Objectives

  • To compare the safety of concomitant AF ablation using HIFU to no ablation in patients with persistent or long standing persistent AF undergoing CABG.
  • To compare AF burden in patients with persistent or long standing persistent AF treated with concomitant HIFU AF ablation undergoing CABG to those receiving no ablation.
  • To compare the quality of life of patients with persistent or long standing persistent AF treated with concomitant HIFU AF ablation undergoing CABG to those receiving no ablation.
  • To compare the health economic impact of concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG to those receiving no ablation.
  • To compare the morbidity associated with persistent or long standing persistent AF in patients following CABG and ablation compared to those receiving no ablation.
  • To compare cardiac function and left atrial transport associated with persistent or long standing persistent AF patients following CABG and ablation compared to those receiving no ablation.
  • To document the incidence of immediate post ablation bidirectional conduction block through the pulmonary venous cinch and mitral lines.
  • To document the effect of Intra-operative pre and post ablation stimulation and ablation of the autonomic ganglia.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elisabeth II Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Finland
    • Western Finland
      • Tampere, Western Finland, Finland, 33520
        • Tampere University Hospital
  • Germany
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45138
        • Herzzentrum Essen
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23562
        • Universitatsklinikum Schleswig Holstein Campus Luebeck
  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
  • Norway
      • Feiring, Norway, 2093
        • Feiringklinikken
      • Oslo, Norway, 0027
        • Rikshospitalet
  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom
        • Derriford Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Legal age in host country
  • Scheduled for CABG surgery
  • Patient suffering from persistent or long-standing persistent AF
  • Patients having the ability to fully comply with the study requirements
  • Life expectancy > 2 years
  • Patients who have given written informed consent to participate in the study

Exclusion Criteria:

  • Clinically significant local or systemic infection or active endocarditis
  • Sutures, pacing/defibrillator leads on the left side of the heart, valve prostheses or rings, or other implanted material in or adjacent to target treatment area.
  • Stent in the coronary artery preventing an adequate mitral line
  • Any other concomitant operation on the heart
  • Previous heart surgery
  • Patients who are or may potentially be pregnant
  • Previous catheter ablation for atrial arrhythmia
  • LA size more than 60 mm in apical view on Trans-Thoracic Echocardiogram (TTE)
  • LA thrombus on intra-operative Trans-Oesophageal Echocardiogram (TOE)
  • Known contraindication to Amiodarone
  • Inability to undergo TOE
  • Patients who are unable to give full informed consent for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Concomitant HIFU ablation
HIFU AF Ablation
Device: HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
Other Names:
  • • Epicor™ UltraCinch™ LP Ablation Device
  • • Epicor™ UltraWand™ LP Tissue Ablation Wand
  • • Epicor™ LP Positioning and Sizing (LP PAS™) System
  • • Epicor™ LP Oblique Introducer
NO_INTERVENTION: Best medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor)
Time Frame: 18 months
18 months
Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)
Time Frame: 24 months
24 months
AF burden (determined by 24 and 72 hour Holter monitor).
Time Frame: 24 months
24 months
Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay
Time Frame: 24 months
24 months
Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death
Time Frame: 24 months
24 months
LV function and dimensions and LA size/transport capability
Time Frame: 24 months
24 months
Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines
Time Frame: At intervention
At intervention
Effect of autonomic ganglia stimulation pre and post ablation intra-operatively
Time Frame: Discharge
Discharge
Quality of life measurements (SF-36)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Malcolm Dalrymple-Hay, Mr., Derriford Hospital, Plymouth, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF07004AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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