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

November 13, 2019 updated by: Transseptal Solutions Ltd.

Clinical Study of the TSP Crosser System For Transseptal Access and Left Atrial Catheter Navigation in Patients Undergoing Atrial Fibrillation Ablation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • CHU BICHAT-Claude BERNARD
  • Germany
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: TSP Crosser Transseptal Access System
for transseptal puncture, left atrial access and catheter navigation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ability to achieve transseptal access
Time Frame: intraoperative
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
Time Frame: intraoperative
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
Time Frame: intraoperative
TSP Crosser System usability, graded by the investigators with a Likert scale (from 1 = unacceptable to 5 = excellent, unit value)
intraoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at the end of procedure; up to 10 days from index treatment; at 30 days after index treatment
Duration of Procedural Endpoints
Time Frame: intraoperative
  • 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).
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Transseptal Solutions Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Meditrial Europe Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Monica Tocchi, MD, PhD, Meditrial Europe Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-14-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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