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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TSP Crosser Transseptal Access System
Sponsored by
Transseptal Solutions Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Transseptal puncture, Atrial fibrillation ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

TSP Crosser Transseptal Access System

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall serious adverse events (SAE)/complication rate (in percentage). Complications will be analyzed and grouped as device-related, procedure-related and other complications.
Duration of Procedural Endpoints
Evaluation of the time to achieve left atrial access (in minutes) Total procedural time (in minutes) Total fluoroscopy time (in minutes) Left atrial mapping time (in minutes) Radiofrequency pulmonary veins isolation time (in minutes).

Full Information

First Posted
January 13, 2015
Last Updated
November 13, 2019
Sponsor
Transseptal Solutions Ltd.
Collaborators
Meditrial Europe Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02351999
Brief Title
Clinical Study of the TSP Crosser System for Transseptal Access and Left Atrial Catheter Navigation
Official Title
Clinical Study of the TSP Crosser System For Transseptal Access and Left Atrial Catheter Navigation in Patients Undergoing Atrial Fibrillation Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transseptal Solutions Ltd.
Collaborators
Meditrial Europe Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Transseptal (TS) catheterization is a critical step for left atrial (LA) interventions (atrial fibrillation ablation, LA appendage closure, mitral valve interventions). The availability of suitable tools and techniques is essential to safely perform the TS puncture, effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult procedural situations in which complications may arise. This study is intended to assess the safety, performance and usability of the TSP Crosser System in facilitating access to the left atrium and catheter navigation to the pulmonary veins (PV) during catheter based ablation procedures for the treatment of atrial fibrillation (AF). Moreover, the study will assess the impact of the TSP Crosser System on procedural times, including time to achieve left atrial accesses, total procedure times, total fluoroscopy time, left atrial mapping time and radiofrequency isolation times. The study is a prospective, multicenter, non-randomized single arm interventional investigation. Enrolled subjects who meet the study inclusion/exclusion criteria will be evaluated during the catheter mapping and ablation procedures and followed until release from hospital post procedure per institutional standard of care. After 30 days, patient will be contacted by telephone to obtain information on their clinical condition and any adverse events; if necessary, a clinic visit may be performed when required by the physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Transseptal puncture, Atrial fibrillation ablation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TSP Crosser Transseptal Access System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TSP Crosser Transseptal Access System
Intervention Description
for transseptal puncture, left atrial access and catheter navigation.
Primary Outcome Measure Information:
Title
Ability to achieve transseptal access
Description
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)
Time Frame
intraoperative
Title
TSP Crosser Introducer steerability and positioning for ablation catheter placement
Description
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)
Time Frame
intraoperative
Title
TSP Crosser System usability
Description
TSP Crosser System usability, graded by the investigators with a Likert scale (from 1 = unacceptable to 5 = excellent, unit value)
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
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
Title
Duration of Procedural Endpoints
Description
Evaluation of the time to achieve left atrial access (in minutes) Total procedural time (in minutes) Total fluoroscopy time (in minutes) Left atrial mapping time (in minutes) Radiofrequency pulmonary veins isolation time (in minutes).
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Tocchi, MD, PhD
Organizational Affiliation
Meditrial Europe Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
CHU Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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