TOCCATA - Touch+™ for Catheter Ablation (TOCCATA)

January 28, 2019 updated by: Abbott Medical Devices

A Prospective Safety, Performance and Preliminary Effectiveness, Multi-centre, Clinical Investigation Using the Irrigated TactiCath™ Percutaneous Ablation Catheter for the Treatment of Supra-Ventricular Tachyarrhythmia Using RF Ablation

The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure.

Performance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations.

Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia [AVNRT], accessory pathway Wolff Parkinson White [WPW] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation

Exclusion Criteria:

  • Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery
  • Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart
  • Known cerebrovascular disease, including a history of stroke or transient ischemic attack
  • Left ventricular ejection fraction of <35%
  • Previous heart ablation procedure (surgical or catheter) to the target chamber

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Atrial Fibrillation
Device: Contact force assisted irrigated RF ablation
radiofrequency ablation of atrial fibrillation or SVT
Other Names:
  • TactiCath®
  • TactiSys®
EXPERIMENTAL: Right-sided Supraventricular Tachycardia
Device: Contact force assisted irrigated RF ablation
radiofrequency ablation of atrial fibrillation or SVT
Other Names:
  • TactiCath®
  • TactiSys®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Operative and Post-operative Serious Adverse Events
Time Frame: 3 months for AF arm; 7 days for the right SVT arm

For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.

For AF patients 3 months (±2 weeks)following the index procedure.
3 months for AF arm; 7 days for the right SVT arm

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Collaborators

Endosense

Investigators

  • Principal Investigator: Karl-Heinz Kuck, Prof, Asklepios Klinik St. Georg, Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (ESTIMATE)

October 19, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-001 147

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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