NCT04078685

Brief Summary

The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters (used in a "non-irrigated" mode) in these procedures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 12, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

September 2, 2019

Last Update Submit

September 1, 2020

Conditions

Tachycardia; Paroxysmal, SupraventricularTachycardia, Supraventricular

Outcome Measures

Primary Outcomes (1)

  • Number of radiofrequency applications

    The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT

    From the beginning till the end of the ablation procedure

Secondary Outcomes (7)

  • Overall duration of radiofrequency applications

    From the beginning till the end of the ablation procedure

  • Long-term procedural success

    At 12 months

  • Acute procedural success/failure

    at the end of the ablation procedure

  • Fluoroscopy time

    From the beginning till the end of the ablation procedure

  • Total duration of procedure

    From the beginning till the end of the ablation procedure

  • +2 more secondary outcomes

Study Arms (2)

CONVENTIONAL group

ACTIVE COMPARATOR

Patients with supraventricular tachycardia treated with radiofrequency ablation using a standard (non-contact-force sensing) ablation catheter

Procedure: Standard catheter ablation

CONTACT-FORCE group

EXPERIMENTAL

Patients with supraventricular tachycardia treated with radiofrequency ablation using a Contact-Force-sensing ablation catheter

Procedure: Contact Force-sensing-based catheter ablation

Interventions

Standard catheter ablationPROCEDURE

Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing

CONVENTIONAL group
Contact Force-sensing-based catheter ablationPROCEDURE

Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter

CONTACT-FORCE group

Eligibility Criteria

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

You may qualify if:

  • Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT
  • Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study
  • Verbal consent to continue with ablation therapy
  • Informed written consent to be included in the study

You may not qualify if:

  • evidence of structural heart disease and/or myocardial ischemia
  • age below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (9)

  • Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.

    PMID: 25220575BACKGROUND

  • Gerstenfeld EP. Contact force-sensing catheters: evolution or revolution in catheter ablation technology? Circ Arrhythm Electrophysiol. 2014 Feb;7(1):5-6. doi: 10.1161/CIRCEP.114.001424. No abstract available.

    PMID: 24550405BACKGROUND

  • Shurrab M, Di Biase L, Briceno DF, Kaoutskaia A, Haj-Yahia S, Newman D, Lashevsky I, Nakagawa H, Crystal E. Impact of Contact Force Technology on Atrial Fibrillation Ablation: A Meta-Analysis. J Am Heart Assoc. 2015 Sep 21;4(9):e002476. doi: 10.1161/JAHA.115.002476.

    PMID: 26391136BACKGROUND

  • Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3.

    PMID: 26041872BACKGROUND

  • Kimura M, Sasaki S, Owada S, Horiuchi D, Sasaki K, Itoh T, Ishida Y, Kinjo T, Tomita H, Okumura K. Comparison of lesion formation between contact force-guided and non-guided circumferential pulmonary vein isolation: a prospective, randomized study. Heart Rhythm. 2014 Jun;11(6):984-91. doi: 10.1016/j.hrthm.2014.03.019. Epub 2014 Mar 18.

    PMID: 24657428BACKGROUND

  • 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: 21872560BACKGROUND

  • Martinek M, Lemes C, Sigmund E, Derndorfer M, Aichinger J, Winter S, Nesser HJ, Purerfellner H. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012 Nov;35(11):1312-8. doi: 10.1111/j.1540-8159.2012.03503.x. Epub 2012 Sep 4.

    PMID: 22946636BACKGROUND

  • Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.

    PMID: 25125294BACKGROUND

  • Geczy T, Ramdat Misier NL, Szili-Torok T. Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH): a randomized controlled trial. Trials. 2020 Apr 9;21(1):321. doi: 10.1186/s13063-020-4219-1.

    PMID: 32272969DERIVED

MeSH Terms

Conditions

Tachycardia, VentricularTachycardia, Supraventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tamas Szili-Torok, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 6, 2019

Study Start

June 12, 2018

Primary Completion

March 9, 2020

Study Completion

March 20, 2021

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)