Coronary ArteriosclerosisAFMAZE-CABGNCT00735722
A(f)MAZE-CABG Study
A study testing HIFU AF Ablation in people with Coronary Arteriosclerosis and Atrial Fibrillation, run by Abbott Medical Devices at 10 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Atrial Fibrillation, Coronary Artery Bypass Graft Surgery
- What is being tested?
- HIFU AF Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Jul 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Canada2 sites
Queen Elisabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Germany2 sites
Herzzentrum Essen
Essen, North Rhine-Westphalia, 45138
Universitatsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Schleswig-Holstein, 23562
United Kingdom2 sites
Derriford Hospital
Plymouth, Devon
Southampton University Hospital
Southampton, Hampshire, SO16 6YD
About this study
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
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.
Read the 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.
- Being tested
- HIFU AF Ablation
- Keywords
- AF, CAD
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU AF AblationDevice
Also called • Epicor™ UltraCinch™ LP Ablation Device, • Epicor™ UltraWand™ LP Tissue Ablation Wand, • Epicor™ LP Positioning and Sizing (LP PAS™) System, • Epicor™ LP Oblique Introducer
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
| Study group | Role | What they receive |
|---|---|---|
| Concomitant HIFU ablation | Active comparator | HIFU AF Ablation Receives: Device: HIFU AF Ablation |
| Best medical treatment | No intervention | Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months
Measured: 12 months
Secondary outcomes (9)
Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor)
Measured: 18 months
Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)
Measured: 24 months
AF burden (determined by 24 and 72 hour Holter monitor).
Measured: 24 months
Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay
Measured: 24 months
Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death
Measured: 24 months
LV function and dimensions and LA size/transport capability
Measured: 24 months
Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines
Measured: At intervention
Effect of autonomic ganglia stimulation pre and post ablation intra-operatively
Measured: Discharge
Quality of life measurements (SF-36)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Malcolm Dalrymple-Hay, Mr., Principal investigator, Derriford Hospital, Plymouth, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735722
- Sponsor's protocol ID
- AF07004AF
- Acronym
- AFMAZE-CABG
- Status last verified
- Jan 2019
- First submitted
- 14 Aug 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00735722
- Acronym / sponsor ID
- AFMAZE-CABG / AF07004AF
- Keywords
- AF, CAD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant HIFU ablation | Active comparator | Device: HIFU AF AblationHIFU AF Ablation |
| Best medical treatment | No intervention | –Best medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFU AF AblationAlso: • Epicor™ UltraCinch™ LP Ablation Device, • Epicor™ UltraWand™ LP Tissue Ablation Wand, • Epicor™ LP Positioning and Sizing (LP PAS™) System, • Epicor™ LP Oblique IntroducerConcomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU) | Device | Concomitant HIFU ablation |
Primary outcome
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months
Time frame: 12 months
9 secondary outcomes
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
Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)
Time frame: 24 months
AF burden (determined by 24 and 72 hour Holter monitor).
Time frame: 24 months
Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay
Time frame: 24 months
Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death
Time frame: 24 months
LV function and dimensions and LA size/transport capability
Time frame: 24 months
Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines
Time frame: At intervention
Effect of autonomic ganglia stimulation pre and post ablation intra-operatively
Time frame: Discharge
Quality of life measurements (SF-36)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Related trials for Coronary Arteriosclerosis
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Not yet recruiting
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
Coronary Artery Disease (CAD)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Dalrymple-Hay, Mr. principal investigator
Derriford Hospital, Plymouth, United Kingdom
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU AF Ablation in people with Coronary Arteriosclerosis and Atrial Fibrillation, run by Abbott Medical Devices at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Germany, Norway, United Kingdom, Finland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.