Clinical Study of the TSP Crosser System for Transseptal Access and Left Atrial Catheter Navigation
Atrial Fibrillation
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Transseptal puncture, Atrial fibrillation ablation
Eligibility Criteria
Inclusion Criteria:
- Patient is referred to receive a catheter ablation procedure for atrial fibrillation, requiring transseptal access and LA catheterization
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection
- Patient age is between 18 and 80 years old
Exclusion Criteria (Procedure Related): The use of the TSP Crosser System is contraindicated in patients with the following conditions:
- Atrial thrombus or tumor or myxoma.
- Previous interatrial septal patch or prosthetic atrial septal defect closure device.
- Interruption of inferior vena cava.
- Giant right atrium (70 mm diameter or more).
- Severe rotational anomalies of the heart or great vessels
- Severe kyphoscoliosis.
- Marked dilation of the ascending aorta.
- Inability to lie flat.
Exclusion Criteria (Clinical): Subjects with following conditions will also be considered unsuitable for enrollment:
- Unstable angina or ongoing myocardial infarction.
- History of recent systemic arterial embolization (within 1 month).
- History of recent Cerebral Vascular Accident (CVA) (within 1 month).
- Active infection or sepsis.
- Enrollment in any other ongoing study protocol.
- Female patient is pregnant or lactating.
- Untreatable allergy to contrast media or device materials in contact with blood or skin (Pebax, PTFE, Nitinol, Stainless steel, Polycarbonate, ABS, silicon, acetal, Pet-P (Ertalyte), POM (Delerin), Polycarbonate).
- Unable to tolerate anticoagulation therapy (heparin or warfarin).
- History of blood clotting (bleeding or thrombotic) abnormalities, with increased risk of bleeding.
- Any other health condition that, in the opinion of the investigator, makes the subject unsuitable for transseptal left atrial catheterization
- Participation in concomitant research studies of investigational products.
- Subject will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
Sites / Locations
- CHU Bichat-Claude Bernard
- Asklepios Klinik St. Georg
Arms of the Study
Arm 1
Experimental
TSP Crosser Transseptal Access System
The TSP Crosser Transseptal Access System is a novel integrated system combining an extendable radiopaque loop wire to aid in localizing the fossa ovalis (FO); an innovative flexible needle to enable controlled selection of the FO puncture site; and a steerable sheath for enhanced maneuvering and orientation of catheters during LA navigation.