The Comparison Between the PVAM and CPVI for the Patients of PAF

NCT ID: NCT03026413

Last Updated: 2018-07-20

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.

Detailed Description

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This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.

Conditions

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Atrial Fibrillation Pulmonary Vein Isolation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PVAM

pulomonary vein antrum modification with contact force monitoring for AF

Group Type EXPERIMENTAL

pulmonary vein antrum modification

Intervention Type PROCEDURE

Control arm

pulmonary vein isolation without contact force

Group Type ACTIVE_COMPARATOR

pulmonary vein antrum modification

Intervention Type PROCEDURE

Interventions

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pulmonary vein antrum modification

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with paroxysmal atrial fibrillation refractory to drugs
* with consent

Exclusion Criteria

* LVEF\<50%
* history of cardiac surgery
* valvular heart disease
* abnormal thyroid function
* left atrial thrombus
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Minglong Chen

Professor and Director of Cardiac EP Vice Director of Dept. of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.

Reference Type RESULT
PMID: 23515263 (View on PubMed)

Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.

Reference Type RESULT
PMID: 22820056 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/22820056

an article about the contact force role in ablation for AF

Other Identifiers

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NJ01

Identifier Type: -

Identifier Source: org_study_id

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