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The VERISMART Trial (VERISMART)

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ablation Catheter
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Flutter

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Documented paroxysmal or persistent atrial flutter

Exclusion Criteria:

  • Inability or unwillingness to receive oral anticoagulation
  • Previous ablation procedure for AFL
  • Unwillingness or inability to complete the required follow up arrangements
  • Concomitant atrial fibrillation

Sites / Locations

  • Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Contact force unblinded

Contact force blinded

ECI unblinded

ECI blinded

Arm Description

Outcomes

Primary Outcome Measures

Time to achieve bi-directional block
Time to achieve bi-directional block (secs) . This is defined as the time from the first lesion to the time that consistent (< one minute) bidirectional block is achieved. Total RF energy required for the whole procedure (sec), and total energy required for ablation (power x ablation time in secs).

Secondary Outcome Measures

Full Information

First Posted
May 18, 2015
Last Updated
August 6, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
Collaborators
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02490033
Brief Title
The VERISMART Trial
Acronym
VERISMART
Official Title
Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (undefined)
Primary Completion Date
January 6, 2017 (Actual)
Study Completion Date
October 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
Collaborators
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contact force unblinded
Arm Type
Other
Arm Title
Contact force blinded
Arm Type
Other
Arm Title
ECI unblinded
Arm Type
Other
Arm Title
ECI blinded
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Ablation Catheter
Primary Outcome Measure Information:
Title
Time to achieve bi-directional block
Description
Time to achieve bi-directional block (secs) . This is defined as the time from the first lesion to the time that consistent (< one minute) bidirectional block is achieved. Total RF energy required for the whole procedure (sec), and total energy required for ablation (power x ablation time in secs).
Time Frame
up to 60 Seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Documented paroxysmal or persistent atrial flutter Exclusion Criteria: Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for AFL Unwillingness or inability to complete the required follow up arrangements Concomitant atrial fibrillation
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS1 3HE,
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30943196
Citation
Begg GA, O'Neill J, Sohaib A, McLean A, Pepper CB, Graham LN, Hogarth AJ, Page SP, Gillott RG, Hill N, Walshaw J, Schilling RJ, Kanagaratnam P, Tayebjee MH. Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial). PLoS One. 2019 Apr 3;14(4):e0212903. doi: 10.1371/journal.pone.0212903. eCollection 2019.
Results Reference
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The VERISMART Trial

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