Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies

Catheter Robotics

Status: Completed

Conditions: Atrial Flutter; Ventricular Tachycardia

Treatments: Device: Amigo catheter robot

Study type: Interventional

Funder types: Industry

Identifiers

NCT01139814

2008-001-01

Details and patient eligibility

About

The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. > 18years of age.
2. Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia).
3. Willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure.
4. Completion of Informed Consent.

Exclusion criteria

1. Any contraindication to cardiac catheterization, including pregnancy.

2. Enrollment in any other ongoing cardiac device trial.

3. Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.

4. Corrected or uncorrected atrial septal defect (ASD).

5. Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).

6. Medical condition that will require anticoagulation during study or ablation procedure.

7. Presence of atrial fibrillation or atrial flutter at time of study procedure.

8. Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

181 participants in 1 patient group

Catheter Robot

Experimental group

Description:

device

Treatment:

Device: Amigo catheter robot