NCT01223469

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable atrial-fibrillation

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

September 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

June 3, 2014

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

October 18, 2010

Results QC Date

March 24, 2014

Last Update Submit

January 28, 2019

Conditions

Atrial FibrillationTachycardia, Supraventricular

Keywords

Atrial FibrillationSupraventricular TachycardiaContact ForceRF AblationRadiofrequencyPulmonary Vein IsolationParoxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Operative and Post-operative Serious Adverse Events

    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

Study Arms (2)

Atrial Fibrillation

EXPERIMENTAL
Device: Contact force assisted irrigated RF ablation

Right-sided Supraventricular Tachycardia

EXPERIMENTAL
Device: Contact force assisted irrigated RF ablation

Interventions

Contact force assisted irrigated RF ablationDEVICE

radiofrequency ablation of atrial fibrillation or SVT

Also known as: TactiCath®, TactiSys®
Atrial FibrillationRight-sided Supraventricular Tachycardia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.

    PMID: 22820056RESULT

  • Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.

    PMID: 21872560RESULT

Related Links

MeSH Terms

Conditions

Atrial FibrillationTachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Results Point of Contact

Title
Hendrik Lambert PhD, VP of Clinical and Regulatory Affairs
Organization
St. Jude Medical/Endosense
Hendrik.Lambert@endosense.com

Study Officials

  • Karl-Heinz Kuck, Prof

    Asklepios Klinik St. Georg, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

September 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 30, 2019

Results First Posted

June 3, 2014

Record last verified: 2019-01