- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490033
The VERISMART Trial (VERISMART)
August 6, 2019 updated by: The Leeds Teaching Hospitals NHS Trust
Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leeds, United Kingdom, LS1 3HE,
- Leeds Teaching Hospitals NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Contact force unblinded
|
|
Other: Contact force blinded
|
|
Other: ECI unblinded
|
|
Other: ECI blinded
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to achieve bi-directional block
Time Frame: up to 60 Seconds
|
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). |
up to 60 Seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
January 6, 2017
Study Completion (Actual)
October 28, 2018
Study Registration Dates
First Submitted
May 18, 2015
First Submitted That Met QC Criteria
July 2, 2015
First Posted (Estimate)
July 3, 2015
Study Record Updates
Last Update Posted (Actual)
August 8, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD13/11009
- 14/YH/0038 (Other Identifier: Research Ethics Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Flutter
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
University of PennsylvaniaWithdrawnTypical Atrial Flutter | Risk Factors With Future Development of Atrial FlutterUnited States
-
Angelo BivianoCompleted
-
Kaiser PermanenteActive, not recruitingAtrial Fibrillation and FlutterUnited States
-
Charles University, Czech RepublicCompleted
-
Hospital Universitario Central de AsturiasJohnson & JohnsonUnknown
-
Hangzhou Dinova EP Technology Co., LtdNot yet recruiting
-
University of ManchesterManchester University NHS Foundation TrustWithdrawn
-
Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
-
Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
Clinical Trials on Ablation Catheter
-
Charles University, Czech RepublicRecruitingAtrial FibrillationCzechia
-
Sheba Medical CenterMedtronicUnknownPremature Ventricular Contraction
-
Oxford University Hospitals NHS TrustRoyal Bournemouth and Christchurch Hospitals NHS Foundation TrustCompleted
-
Medtronic Cardiac Rhythm and Heart FailureCompletedAtrial Fibrillation | Paroxysmal Atrial FibrillationUnited States, France, Italy, Canada, Czechia
-
Emory UniversityBoston Scientific CorporationCompleted
-
Field MedicalNot yet recruitingVentricular Tachycardia | Ventricular Arrythmia | Ventricular Tachyarrhythmia | PVC - Premature Ventricular Complex | PVC - Premature Ventricular ContractionCzechia
-
The Cleveland ClinicAtriCure, Inc.Not yet recruitingHeart Failure | Atrial FibrillationUnited States
-
Medtronic Bakken Research CenterTerminatedAtrial FibrillationNetherlands
-
China National Center for Cardiovascular DiseasesNot yet recruitingConcomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic CardiomyopathyAtrial Fibrillation | Cardiomyopathy, Hypertrophic | Radiofrequency AblationChina
-
Maastricht University Medical CenterCompleted