|
| Device | Study | Design | Number of patients | Inclusion criteria | Mean F/U | Results | Comments |
|
| LARIAT | Lee et al. [39] | Prospective | 82 | AF; C/I to warfarin or intolerance to warfarin or pts who have had an embolic event on whilst on warfarin | 3 months | 96% of patients with successful closure continued to have complete closure at 1 month | (i) Requires both endocardial and epicardial access
(ii) Unsuitable in patients with possible pericardial adhesions
(e.g., prior history of coronary artery bypass surgery, valvular surgery, pericarditis, and chest radiotherapy)
(iii) Clinical trial data pending
(iv) FDA and CE mark
APPROVED for commercial use |
|
| WATCHMAN |
Reddy et al. (PROTECT AF) [33] | RCT | 707 | Permanent or paroxysmal AF; CHADS2 ≥ 1; suitable for warfarin | 18 months | Probability of noninferiority of the intervention was more than 99.9% | (i) Efficacy demonstrated in
clinical trial
(ii) CE mark APPROVED for commercial use |
|
| AMPLATZER cardiac plug | Park et al. [35] | Registry | 141 | Permanent or paroxysmal AF | 24 hours after-implantation | Stroke 2.1% Device embolisation 1.4% Pericardial tamponade 3.5% | (i) Clinical trial data pending
(ii) CE mark APPROVED for commercial use |
|
| AMPLATZER septal occluder | Meier et al. [28] | Prospective | 16 | Permanent or paroxysmal AF;
C/I to warfarin | 4 months | TIA/stroke 0%
Device embolisation 6.3% | (i) Not a dedicated LAA occluder
(ii) Has been superseded by the AMPLATZER Cardiac Plug for
LAA occlusion
(iii) Not in Commercial use |
|
| PLAATO | Ostermayer et al. [30] | Prospective | 111 | Permanent nonrheumatic AF; patients at risk for stroke; C/I to warfarin | 10 months | TIA/stroke 2.2% | (i) No longer available for clinical use |
| Block et al. [31] | Prospective | 64 | Permanent or paroxysmal AF; CHADS2 ≥ 2;
C/I to warfarin | 5 years | Stroke: 3.8% |
|
| Coherex Wave Crest |
Muller (currently recruiting) [36] | Prospective | 52- actively recruiting | Permanent or paroxysmal nonvalvular AF; CHADS2 ≥ 1 | | Data available on 10 cases only, 1 embolic event | (i) Retractable coils and anchors to enable optimal device positioning
(ii) Clinical trial data pending
(iii) Not in commercial use |
|
