NCT02493075

Brief Summary

The objective of the study is:Phase I: To validate or otherwise determine the Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the effectiveness and safety of ablation guided by the appropriate contact force.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_1 atrial-fibrillation

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

June 25, 2015

Last Update Submit

July 8, 2015

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationCatheter Ablationcontact forceChinese-specific

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation (AF) recurrence rate

    Patients will be followed up at 1, 3, 6, 9, 12months post ablation. Patients' experiences, 12-lead electrocardiograms (ECGs) and Holter monitoring (non-required at 1, 9 months) will be recorded to evaluate recurrence at each appointment (not including 1 and 3 month visit post procedure) and any visits when the patient experience symptoms that suggestive of arrhythmia. The first 3 months is considered as a blanking period.Recurrence is defined as AF/flutter/tachycardia, lasting longer than 30s, that documented by an ECG or Holter recording, or highly suggestive symptoms, after 3 months post-procedure.

    one year

Secondary Outcomes (2)

  • Time Data related with procedure

    intraoperative

  • Number of participants with Mortality and complications

    one year

Study Arms (2)

CF guided group

EXPERIMENTAL

Ablation will be performed with smart-touch catheter.The operator will kown the real-time contact force (CF), ablation time, FTI, etc during the procedure.

Behavioral: The operator blinded to the contact force data or not.

Usual ablation group

ACTIVE COMPARATOR

Although we use the same catheter,operator will be blinded to CF data during the procedure.

Behavioral: The operator blinded to the contact force data or not.

Interventions

The operator blinded to the contact force data or not.BEHAVIORAL

CF guided group: ablation will be performed with the guidance of real-time CF, ablation time, FTI, etc. CF will be controlled in the range of "appropriate CF", which has been defined in phase I. Circumferential PV ablation will be performed orderly, "isolated segment"," acute reconnected segment ", and "unisolated segment" will be also identified as described in phase I. Usual ablation group: Operator will be blinded to CF data, the procedure performance is the same as described in phase I.

CF guided groupUsual ablation group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 - 75 years
  • Symptomatic PAF refractory to at least one antiarrhythmic drug
  • Minimum of two episodes of recurrent self-terminating AF within prior 12 months and with latest documented episode within 6 months prior ablation procedure
  • First catheter ablation
  • Patient is able and willing to provide written informed consent.

You may not qualify if:

  • Persistent or long-standing persistent AF
  • \>4 cardioversions in prior 12 months
  • Myocardial infarction(MI), coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
  • Left atrial diameter \>5.0 cm or \<3.5 cm
  • Left ventricular ejection fraction by echocardiography \<40%
  • New York Heart Association（NYHA）class III or IV
  • History of heart surgery or any previous ablation for AF
  • Intracardiac thrombus
  • Females who are pregnant or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orphan Nuclear ReceptorsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cytoplasmic and Nuclear

Study Officials

  • Chenyang Jiang, MD

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenyang Jiang, MD

CONTACT

+86 13857190051jiangchenyang@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 9, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

CN(1)