Primary efficacy objective: to test that patients with permanent or persistent AF and concomitant diseases requiring open heart surgery will be free of AF when treated with the Cardioblate Surgical Ablation System using a modified Maze III procedure…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occurrence of AF after ablation
Secondary outcome
Use of antiarrhythmic medication and antithromboembolic mediaction after
ablation.
Background summary
The Cardioblate Surgical Ablation System is cleared in Canada and Europe for
ablation of cardiac tissue for the treatment of cardiac arrhythmias. In the
United States, the Cardioblate bipolar is approved for soft tissue ablation,
while the Cardioblate Pen is approved for cardiac tissue ablation. The purpose
of the clinical study is to obtain a labeling claim for the US market that the
Cardioblate Surgical Ablation System can be used for ablation of cardiac tissue
in the treatment of cardiac arrhythmias such as atrial fibrillation among
permanent and persistent AF patients.
Study objective
Primary efficacy objective: to test that patients with permanent or persistent
AF and concomitant diseases requiring open heart surgery will be free of AF
when treated with the Cardioblate Surgical Ablation System using a modified
Maze III procedure.
Primary safety objective: to demonstrate that the Cardioblate Surgical Ablation
System can safely treat permanent or persistent AF patients requiring
concomitant open heart surgery.
Both the efficacy and the safety objective of this study will be analyzed for
patients with permanent AF and patients with persistent AF separately.
Study design
A prospective, non-randomized, multi-center clinical trial
Intervention
Radio frequency ablation of the right and left atrium during open heart surgery
Study burden and risks
The additional time required for the Cardioblate procedure and the potential
adverse events related to the Cardioblate procedure are minimal in comparison
to the risks associated with the concomitant procedure. Risks associated with
use of the Cardioblate Surgical Ablation System and concomitant open heart
surgery include but are not limited to pericardial effusion / tamponade,
thromboembolism, myocardial infarction, irregular cardiac rhythm, cardiac
conduction system damage, heart valve damage, damage to adjacent structures or
tissue, such as esophageal perforation, injury or damage to great vessels,
tissue perforation, unintended burns and pericarditis.
If the patient*s AF is successfully treated, the patient might be able to
discontinue anti-arrhythmic medication, many of which have significant side
effects. In addition, anticoagulation medication, if no other indications
exist, as well as other therapies being used to treat AF might be discontinued.
In addition, the long-term risk for thrombo-embolisms and stroke might be
reduced.
Endepolsdomein 5
6229 GW Maastricht
Nederland
Endepolsdomein 5
6229 GW Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
1 Documented history of AF
2 Concomitant indication (other than AF) for open-heart surgery
3 Able to take the anticoagulant warfarin
4 Greater than or equal to 18 years of age;
5 Able and willing to comply with study requirements by signing a Patient Informed Consent form.
Exclusion criteria
1 NYHA functional class = IV,
2 Left ventricular ejection fraction < 30%,
3 Left atrial diameter > 7.0 cm,
4 Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery,
5 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure,
6 Pregnancy or desire to be pregnant within 12-months of the study treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27687.060.09 |