NCT01278953

Brief Summary

The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied. A second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 8, 2016

Completed
Last Updated

February 21, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

January 17, 2011

Results QC Date

January 7, 2016

Last Update Submit

January 29, 2019

Conditions

Paroxysmal Atrial Fibrillation

Keywords

paroxysmal atrial fibrillationatrial fibrillationradiofrequency ablationpulmonary vein isolationablation catheterRFcontact force sensingcontact forcecontact force assisted ablation

Outcome Measures

Primary Outcomes (2)

  • Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter

    Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.

    12 months

  • Incidence of Device-related Early-onset Primary Serious Adverse Events

    Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.

    12 months

Study Arms (2)

TactiCath

EXPERIMENTAL

Catheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability

Device: Catheter ablation to treat paroxysmal atrial fibrillation

Control

ACTIVE COMPARATOR

Catheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability

Device: Catheter ablation to treat paroxysmal atrial fibrillation

Interventions

Catheter ablation to treat paroxysmal atrial fibrillationDEVICE

A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

ControlTactiCath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug
  • minimum one documented PAF episode \>30 sec duration within prior 12 months
  • minimum three PAF episodes during prior 12 months
  • years or older

You may not qualify if:

  • persistent or long-standing persistent AF
  • four or more cardioversions in prior 12 months
  • MI, CABG or PCI within preceding 3 months
  • left atrial diameter \> 5.0 cm
  • LVEF \< 35%
  • NYHA class III or IV
  • previous left atrial ablation procedure
  • previous tricuspid or mitral valve repair surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (1)

  • Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.

    PMID: 26260733DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lori Rusch, Ph.D.
Organization
Abbott
lori.rusch@abbott.com
651-756-2668

Study Officials

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

September 1, 2015

Last Updated

February 21, 2019

Results First Posted

February 8, 2016

Record last verified: 2019-01

Locations

US(1)