Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study) (RECREATION)

September 5, 2019 updated by: Qi Jin, Ruijin Hospital

Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study

Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
  2. Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
  3. Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
  4. Compare the effects of amiodarone on recurrence after these two different ablation procedures.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Persistent atrial fibrillation (>7d, < 5years)
  2. Age 18-75 years
  3. Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol

Exclusion Criteria:

  1. Any previous left atrial ablation or surgery
  2. Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment
  3. Stroke or transient ischemic attack within 6 months prior to enrollment
  4. Myocardial infarction within 3 months prior to enrollment
  5. Anteroposterior left atrial diameter > 55 mm

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote magnetic navigation
Persistent atrial fibrillation ablation with remote magnetic navigation
Procedure: Remote magnetic navigation
Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
Active Comparator: Cryoablation
Persistent atrial fibrillation ablation with cryoballoon
Procedure: Cryoablation
Pulmonary vein isolation and other areas ablation used by cryoballoon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy (time to first AF recurrence after blanking period)
Time Frame: one year
the time to first AF recurrence after blanking period (month)
one year
Clinical safety (Any procedure-related complications)
Time Frame: one year
Any procedure-related complications
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure time (min)
Time Frame: one week
one week
Time to first cardiovascular hospitalization (month)
Time Frame: one year
one year
QoL of 12 months (Units on a Scale)
Time Frame: one year
one year
X-ray time (min)
Time Frame: one week
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Qi Jin, MD, Ruijin Hospital

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.

General Publications

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 (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20161404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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