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

NCT02351999 | Completed

• 1 other identifier: CR-14-01
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

The study is a prospective, multi-center, non-randomized single arm interventional investigation with the TSP Crosser Transseptal Access System, a new complete solution for transseptal puncture and left atrial access and catheter navigation, for patients with atrial fibrillation ablation referred for radiofrequency catheter ablation.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Transseptal puncture; Atrial fibrillation ablation

Outcome Measures

Primary Outcomes (3)

• Ability to achieve transseptal access

  Ability to achieve transseptal access with the TSP Crosser needle with the aid of the loopwire for locating the fossa ovalis. The ability to achieve transseptal access will be assess by the successful puncture of the TSP Crosser needle and by the utility of TSP Crosser loop wire for locating the fossa ovalis (graded by the investigators with a Likert scale: from 1 = unacceptable to 5 = excellent, unit value)

  intraoperative

• TSP Crosser Introducer steerability and positioning for ablation catheter placement

  TSP Crosser Introducer steerability and positioning to facilitate ablation catheter placement as seen fluoroscopically and by ability to visualize navigation of ablation catheter to the pulmonary veins. Outcome will be assessed by ability of ablation catheter to be inserted and retrieved through the sheath visualized fluoroscopically during the procedure, graded by the investigators with a Likert scale (from 1 = unacceptable to 5 = excellent, unit value)

  intraoperative

• TSP Crosser System usability

  TSP Crosser System usability, graded by the investigators with a Likert scale (from 1 = unacceptable to 5 = excellent, unit value)

  intraoperative

Secondary Outcomes (2)

• Overall serious adverse events (SAE)/complication rate (in percentage). Complications will be analyzed and grouped as device-related, procedure-related and other complications.

  at the end of procedure; up to 10 days from index treatment; at 30 days after index treatment

• Duration of Procedural Endpoints

  intraoperative

Study Arms (1)

TSP Crosser Transseptal Access System

EXPERIMENTAL

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.

Device: TSP Crosser Transseptal Access System

Interventions

TSP Crosser Transseptal Access System DEVICE

for transseptal puncture, left atrial access and catheter navigation.

TSP Crosser Transseptal Access System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Transseptal Solutions Ltd.: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (2)

CHU Bichat-Claude Bernard

Paris, 75018, France

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Tocchi, MD, PhD

  Meditrial Europe Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 30, 2015
• Study Start: June 15, 2015
• Primary Completion: September 1, 2018
• Study Completion: April 1, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-11

Locations

DE (1); FR (1)