High-density Mapping-guided bOx Isolation and subsTrate Ablation (HOT)

June 28, 2019 updated by: The Third Xiangya Hospital of Central South University

Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation

This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  • Informed consent signed.
  • Age of 18 to 75 years old.
  • Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
  • Willing to have catheter ablation for atrial fibrillation.

Exclusion Criteria:

  • Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
  • Complete atrioventricular block.
  • An acute stroke or contradiction of anti-coagulation.
  • Hyperthyroidism.
  • Having a history of catheter ablation of atrial fibrillation.
  • Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
  • Pregnancy or lactation.
  • Planning for pregnancy in the near future.
  • Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
  • Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Circumferential PV isolation
Circumferential PV isolation only
Procedure: CPVI
Circumferential PV isolation only
Experimental: Circumferential PV and BOX isolation
Procedure: CPVI+BOX
Circumferential PV and BOX isolation
Experimental: circumferential PV and BOX isolation with substrate ablation
Atrial substrate ablation apart from circumferential PV and BOX isolation
Procedure: CPVI+BOX+SUB
Atrial substrate ablation apart from circumferential PV and BOX isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sinus rhythm maintenance rate
Time Frame: 12 months
Holter is performed 12months after the procedure and heart rhythm is recorded.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular ejection fraction
Time Frame: 12 months
LVEF is evaluated by echocardiography 12months after the procedure.
12 months
Stroke or embolic events
Time Frame: 12 months
History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
12 months
Atrial fibrosis
Time Frame: 1 day
Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.
1 day

Collaborators and Investigators

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

Sponsor

The Third Xiangya Hospital of Central South University

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 (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3rdxiangya@csu

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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