Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter

NCT ID: NCT02825498

Last Updated: 2020-05-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-18

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Flutter Radiofrequency Catheter Ablation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Operator guided by contact force

Operator has full access to contact force parameters including force time integral (FTI).

Group Type EXPERIMENTAL

Contact force guided RFA

Intervention Type DEVICE

Contact force guided RFA during Atrial Flutter ablation procedure.

Operator blinded to contact force

Operator is blinded to contact force with ablation guided by standard markers of effective ablation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contact force guided RFA

Contact force guided RFA during Atrial Flutter ablation procedure.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
* Able and willing to give informed consent.

Exclusion Criteria

* Previous CTI ablation
* Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Victoria Cardiac Arrhythmia Trials

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Novak, MD

Role: PRINCIPAL_INVESTIGATOR

Victoria Cardiac Arrhythmia Trials

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C2016-012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.