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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00735722
Other study ID # AF07004AF
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2009
Est. completion date August 2012

Study information

Verified date January 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 ablation.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 188
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)

Locations

Country Name City State
Canada Queen Elisabeth II Health Sciences Centre Halifax Nova Scotia
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Finland Tampere University Hospital Tampere Western Finland
Germany Herzzentrum Essen Essen North Rhine-Westphalia
Germany Universitatsklinikum Schleswig Holstein Campus Luebeck Luebeck Schleswig-Holstein
Netherlands Catharina Ziekenhuis Eindhoven Noord-Brabant
Norway Feiringklinikken Feiring
Norway Rikshospitalet Oslo
United Kingdom Derriford Hospital Plymouth Devon
United Kingdom Southampton University Hospital Southampton Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Canada,  Finland,  Germany,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months 12 months
Secondary 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
Secondary Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor) 24 months
Secondary AF burden (determined by 24 and 72 hour Holter monitor). 24 months
Secondary Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay 24 months
Secondary Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death 24 months
Secondary LV function and dimensions and LA size/transport capability 24 months
Secondary Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines At intervention
Secondary Effect of autonomic ganglia stimulation pre and post ablation intra-operatively Discharge
Secondary Quality of life measurements (SF-36) 24 months
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