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出境医 / 临床实验 / Physiologically Guided VT Ablation

Physiologically Guided VT Ablation

Study Description
Brief Summary:
The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Ablation Not Applicable

Detailed Description:

Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.

Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.

The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.

The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
Actual Study Start Date : October 12, 2014
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : January 1, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Study Arm
The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.
 Device: Ablation
Cardiac Ablation
No Intervention: Control
Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.
Outcome Measures
Primary Outcome Measures :
  1. Composite of VT recurrence or death [ Time Frame: 36 months follow-up ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
  3. Planned for first VT ablation procedure.
  4. Patients must have an ICD or a plan for ICD implantation after the ablation.
  5. Ability to understand the requirement of the study and to sign an informed consent.

Exclusion Criteria:

  1. Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
  2. The VT substrate is thought not to be related to coronary disease.
  3. Presence of ongoing ischemia that is thought to be the cause of the VT.
  4. Contraindication to anticoagulation therapy
  5. Stroke within 30 days before enrollment.
  6. Life expectancy <1 year for any medical condition.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE October 12, 2014
Estimated Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		Composite of VT recurrence or death [ Time Frame: 36 months follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiologically Guided VT Ablation
Official Title  ICMJE Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
Brief Summary The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.
Detailed Description

Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.

Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.

The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.

The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Tachycardia
Intervention  ICMJE Device: Ablation
Cardiac Ablation
Study Arms  ICMJE
  • Active Comparator: Study Arm
    The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.
    Intervention: Device: Ablation
  • No Intervention: Control
    Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18 years
  2. History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
  3. Planned for first VT ablation procedure.
  4. Patients must have an ICD or a plan for ICD implantation after the ablation.
  5. Ability to understand the requirement of the study and to sign an informed consent.

Exclusion Criteria:

  1. Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
  2. The VT substrate is thought not to be related to coronary disease.
  3. Presence of ongoing ischemia that is thought to be the cause of the VT.
  4. Contraindication to anticoagulation therapy
  5. Stroke within 30 days before enrollment.
  6. Life expectancy <1 year for any medical condition.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004624
Other Study ID Numbers  ICMJE PhysioVT1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Center for Cardiovascular Reseach and Innovation
Study Sponsor  ICMJE Center for Cardiovascular Reseach and Innovation
Collaborators  ICMJE Boston Scientific Corporation
Investigators  ICMJE Not Provided
PRS Account Center for Cardiovascular Reseach and Innovation
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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