A(f)MAZE-CABG Study | NCT00735722

Studies
A(f)MAZE-CABG Study

NCT00735722

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

188Actual

Phase

Not Applicable

Conditions

Coronary Arteriosclerosis
Atrial Fibrillation
Coronary Artery Bypass Graft Surgery

Interventions

HIFU AF Ablation

Countries

Canada
Finland
Germany
Netherlands
Norway
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Aug 14, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concomitant HIFU ablation	Active Comparator	HIFU AF Ablation	Device: HIFU AF Ablation
Best medical treatment	No Intervention	Best medical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIFU AF Ablation	Device	Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)	Concomitant HIFU ablation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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)		18 months
Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malcolm Dalrymple-Hay, Mr.	Derriford Hospital, Plymouth, United Kingdom	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Elisabeth II Health Sciences Centre		Halifax	Nova Scotia	B3H 3A7	Canada
Sunnybrook Health Sciences Centre

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D004358	Drug Therapy
D013812	Therapeutics