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Trial record 4 of 7 for:    27042964 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03044925
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Qi Jin, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Remote magnetic navigation Procedure: Cryoablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical efficacy (time to first AF recurrence after blanking period) [ Time Frame: one year ]
    the time to first AF recurrence after blanking period (month)

  2. Clinical safety (Any procedure-related complications) [ Time Frame: one year ]
    Any procedure-related complications


Secondary Outcome Measures :
  1. Procedure time (min) [ Time Frame: one week ]
  2. Time to first cardiovascular hospitalization (month) [ Time Frame: one year ]
  3. QoL of 12 months (Units on a Scale) [ Time Frame: one year ]
  4. X-ray time (min) [ Time Frame: one week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044925


Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Qi Jin, MD Ruijin Hospital

Publications of Results:
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Responsible Party: Qi Jin, Clinical Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03044925     History of Changes
Other Study ID Numbers: 20161404
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qi Jin, Ruijin Hospital:
persistent atrial fibrillation
remote magnetic navigation
cryoablation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes