The VERISMART Trial

NCT ID: NCT02490033

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2018-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Contact force unblinded

Group Type OTHER

Ablation Catheter

Intervention Type DEVICE

Contact force blinded

Group Type OTHER

Ablation Catheter

Intervention Type DEVICE

ECI unblinded

Group Type OTHER

Ablation Catheter

Intervention Type DEVICE

ECI blinded

Group Type OTHER

Ablation Catheter

Intervention Type DEVICE

Interventions

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Ablation Catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 30943196 (View on PubMed)

Other Identifiers

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14/YH/0038

Identifier Type: OTHER

Identifier Source: secondary_id

CD13/11009

Identifier Type: -

Identifier Source: org_study_id

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