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ACT DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation (TRAC-AF)

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: NCT02821351
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
EPIX Therapeutics

Brief Summary:
The primary objective of this study is to establish the safety and performance effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF).

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Radio frequency (RF) Cardiac ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DiamondTemp
Bilateral pulmonary vein isolation by RF ablation using DiamondTemp temperature controlled catheter and RF generator/pump system
Device: Radio frequency (RF) Cardiac ablation
Catheter based RF cardiac ablation to treat Paroxysmal Atrial Fibrillation
Other Name: RF Ablation




Primary Outcome Measures :
  1. Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) [ Time Frame: Seven days ]
    The safety of the DiamondTemp System will be assessed by evaluating the nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) during the time of the ablation procedure and within 7 days afterwards.

  2. Electrical Isolation of treated Pulmonary Vein from Left Atrium [ Time Frame: Seven days ]
    The effectiveness of the DiamondTemp System will be evaluated post-ablation with demonstration of acute procedural success defined as isolation of clinically relevant pulmonary veins by demonstration of block or isolation of signals confirmed after delivery of the ablation treatment. Depending on EP lab protocol, one method will be chosen.


Secondary Outcome Measures :
  1. Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) up to a year after treatment [ Time Frame: During 12 months after the treatment ]
    The chronic safety of the DiamondTemp System will be assessed by evaluating the nature and frequency of adverse events (AE) and adverse device effects (ADE) at 30 days, 90 days, 6 months and 12 months post-procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study Inclusion Criteria

Subjects for this study must meet ALL of the following criteria:

  • Suitable candidate for intra-cardiac mapping and ablation for arrhythmias.
  • History of recurrent symptomatic PAF1 WITH ≥2 episodes reported within the 365 days (12) months prior to enrollment.
  • At least one episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
  • Refractory to at least one Class I - IV anti-arrhythmic drug (AAD)
  • Eighteen (18) years of age or above
  • Competent and willing to provide written informed consent to participate in the study and agree to comply with the follow-up visits and evaluation.

Study Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions apply:

  • Previous left atrial ablation procedure
  • Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
  • Known severe cerebrovascular disease or history of cerebrovascular event (within 1 month)
  • Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. This is calculated as follows for males:

GFR = (140 - age) x weight x .85 (for females) PCr x 72 where age is specified in years, weight in kg, and PCr is Serum Creatinine in mg/dL Female GFR is reduced by 15% of the above calculated value for males.

  • Active gastrointestinal bleeding
  • Active infection or fever (> 100.5 F/38 C)
  • Sepsis
  • Cardiac surgery within the past two months
  • Short life expectancy (< 1yr) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease
  • Significant anemia (hemoglobin < 8.0 mg/dL)
  • Severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the last 30 days)
  • Documented anaphylaxis during previous exposure to angiographic contrast media
  • Uncontrolled congestive heart failure (NYHA Class III or IV)
  • Unstable angina or acute myocardial infarction within the past three months
  • Bleeding, clotting disorders, or known thrombosis
  • Severe Peripheral vascular disease
  • Uncontrolled diabetes
  • Rheumatic heart disease
  • Heart valve replacement
  • Mitral clip (Evalve)
  • Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
  • Active participation in another investigational protocol currently or the last 30 days
  • Unable or unwilling to take anti-coagulants
  • Unwilling or unable to comply with any protocol or follow up requirements

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): NCT02821351


Locations
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Czechia
St Anne's University Hospital
Brno, Czechia
Nemocnice Na Homolce
Prague, Czechia
Institut Klinické a Experimentální Medicíny (IKEM)
Praha, Czechia
France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
EPIX Therapeutics
Investigators
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Principal Investigator: Petr Neuzil, MD, PhD Na Homolce Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EPIX Therapeutics
ClinicalTrials.gov Identifier: NCT02821351    
Other Study ID Numbers: DTAF-CZ01
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by EPIX Therapeutics:
Afib
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes