Trials / Terminated
TerminatedNCT00735722
A(f)MAZE-CABG Study
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HIFU AF Ablation | Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU) |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2008-08-15
- Last updated
- 2019-02-04
Locations
10 sites across 6 countries: Canada, Finland, Germany, Netherlands, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT00735722. Inclusion in this directory is not an endorsement.