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Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation (FASTR-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: NCT03626649
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
EPIX Therapeutics

Brief Summary:
The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: DiamondTemp Cardiac Ablation System Not Applicable

Detailed Description:
  • The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
  • In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DiamondTemp Cardiac Ablation System
Cardiac ablation procedure
Device: DiamondTemp Cardiac Ablation System

The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of:

  • DiamondTemp Ablation Catheter

    o Unidirectional and Bidirectional models

  • DiamondTemp Catheter-to RFG Cable
  • DiamondTemp GenConnect Cable
  • DiamondTemp FASTR Generator with Footswitch
  • DiamondTemp Irrigation Pump
  • DiamondTemp Irrigation Tubing Set
Other Name: Cardiac ablation




Primary Outcome Measures :
  1. Freedom from a composite of serious adverse events (SAE) [ Time Frame: 30 days ]
    Freedom from a composite of serious adverse events (SAE)

  2. Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes [ Time Frame: 12 months ]
    Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes


Secondary Outcome Measures :
  1. Freedom from a composite SAE [ Time Frame: 7 days ]
    Freedom from a composite SAE

  2. Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes [ Time Frame: 12 months ]
    Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes

  3. Rate of single procedure success [ Time Frame: 12 months ]
    Rate of single procedure success



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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

Inclusion Criteria:

  • Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
  • History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
  • (12) months prior to enrollment
  • At least 1 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

Exclusion Criteria:

  • 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 (< 1 month)
  • Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding
  • Active infection or fever (>100.5 F/38 ◦C)
  • Sepsis
  • Cardiac surgery within the past two months.
  • Short life expectancy (<1 yr.) 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 pressure > 240 mm Hg within the last 30 days)
  • Documented anaphylaxis during previous exposure to angiographic contrast media
  • Uncontrolled congestive heart failure (NYHA1 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
  • Heart valve replacement
  • Mitral clip (E-valve)
  • 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): NCT03626649


Locations
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Czechia
Na Homolce
Prague, Czechia, 15000
France
Clnique du Tonkin
Lyon, France
CHRU de Nancy
Nancy, France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
EPIX Therapeutics
Investigators
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Principal Investigator: Petr Neuzil, MD, PhD Na Homolce

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Responsible Party: EPIX Therapeutics
ClinicalTrials.gov Identifier: NCT03626649     History of Changes
Other Study ID Numbers: TP00983
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes