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

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00735722
First received: August 14, 2008
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Coronary Arteriosclerosis
Atrial Fibrillation
Coronary Artery Bypass Graft Surgery
Device: HIFU AF Ablation
Drug: Best Medical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • AF burden (determined by 24 and 72 hour Holter monitor). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • LV function and dimensions and LA size/transport capability [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines [ Time Frame: At intervention ] [ Designated as safety issue: No ]
  • Effect of autonomic ganglia stimulation pre and post ablation intra-operatively [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Quality of life measurements (SF-36) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: July 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Concomitant HIFU 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 Drug: Best Medical Therapy
Best Medical Therapy according to local guidelines

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735722

Locations
Canada, Nova Scotia
Queen Elisabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Finland
Tampere University Hospital
Tampere, Western Finland, Finland, 33520
Germany
Herzzentrum Essen
Essen, North Rhine-Westphalia, Germany, 45138
Universitatsklinikum Schleswig Holstein Campus Luebeck
Luebeck, Schleswig-Holstein, Germany, 23562
Netherlands
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Norway
Feiringklinikken
Feiring, Norway, 2093
Rikshospitalet
Oslo, Norway, 0027
United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
Southampton University Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Malcolm Dalrymple-Hay, Mr. Derriford Hospital, Plymouth, United Kingdom
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00735722     History of Changes
Other Study ID Numbers: AF07004AF
Study First Received: August 14, 2008
Last Updated: October 17, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by St. Jude Medical:
AF
CAD

Additional relevant MeSH terms:
Atrial Fibrillation
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease

ClinicalTrials.gov processed this record on September 18, 2014