Clinical Study of the TSP Crosser System for Transseptal Access and Left Atrial Catheter Navigation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02351999
• Date of registration: 13/01/2015
• Prospective Registration: Yes
• Primary sponsor: Transseptal Solutions Ltd.
• Public title: Clinical Study of the TSP Crosser System for Transseptal Access and Left Atrial Catheter Navigation
• Scientific title: Clinical Study of the TSP Crosser System For Transseptal Access and Left Atrial Catheter Navigation in Patients Undergoing Atrial Fibrillation Ablation
• Date of first enrolment: June 15, 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02351999
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France, Germany

Contacts

• Name: Monica Tocchi, MD, PhD
• Affiliation: Meditrial Europe Ltd.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Device: TSP Crosser Transseptal Access System

Primary Outcome(s)

TSP Crosser Introducer steerability and positioning for ablation catheter placement [Time Frame: intraoperative]

Ability to achieve transseptal access [Time Frame: intraoperative]

TSP Crosser System usability [Time Frame: intraoperative]

Secondary Outcome(s)

Duration of Procedural Endpoints [Time Frame: intraoperative]

Overall serious adverse events (SAE)/complication rate (in percentage). Complications will be analyzed and grouped as device-related, procedure-related and other complications. [Time Frame: at the end of procedure; up to 10 days from index treatment; at 30 days after index treatment]

Secondary ID(s)

CR-14-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Meditrial Europe Ltd.