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Trial record 1 of 1 for:    A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation
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DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation (DIAMOND-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: NCT03334630
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
EPIX Therapeutics

Brief Summary:
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Atrial Fibrillation Device: DiamondTemp Ablation catheter Device: TactiCath Quartz Ablation catheter Not Applicable

Detailed Description:
The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : December 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DiamondTemp Ablation Catheter
Catheter ablation to treat paroxysmal atrial fibrillation using temperature-controlled ablation catheter
Device: DiamondTemp Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Active Comparator: TactiCath Quartz Ablation Catheter
Catheter ablation to treat atrial fibrillation using contact-force sensing ablation catheter
Device: TactiCath Quartz Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter




Primary Outcome Measures :
  1. Incidence of Device Related Serious Adverse Events measured at 30 days in all subjects [ Time Frame: 30 days after index ablation procedure ]
    Freedom from a Composite of Pre-Specified Serious Adverse Events

  2. The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up [ Time Frame: 3-12 months after index ablation procedure ]
    The primary effectiveness endpoint for this study will be freedom from documented symptomatic AF, AFL, AT



Information from the National Library of Medicine

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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

Key Inclusion Criteria:

  • Above 18 years of age
  • Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥ 2 episodes of PAF reported within the 12 months prior to index ablation procedure
  • At least one episode of PAF documented by electrocardiographic data within 12 months prior to index ablation procedure and a physician's note indicating recurrent self-terminating AF
  • Failure or intolerance of at least one Class I-IV anti-arrhythmic AAD for treatment of PAF

Exclusion Criteria:

  • LA diameter > 5.5 cm
  • Left ventricular ejection fraction < 35%
  • Currently NYHA Class III or IV or exhibits uncontrolled heart failure
  • Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of the ablation procedure
  • Documented stroke, CVA, TIA or suspected neurological event within 6 months of the ablation procedure

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): NCT03334630


Locations
Show Show 23 study locations
Sponsors and Collaborators
EPIX Therapeutics
Investigators
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Principal Investigator: Josef Kautzner, MD, PhD Institut klinické a experimentální medicíny (IKEM)
Principal Investigator: William Maddox, MD University of Alabama at Birmingham
Principal Investigator: Tom McElderry, MD University of Alabama at Birmingham

Publications:
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Responsible Party: EPIX Therapeutics
ClinicalTrials.gov Identifier: NCT03334630    
Other Study ID Numbers: TP00599
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
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: Yes
Keywords provided by EPIX Therapeutics:
ablation
electrophysiology
atrial fibrillation
catheter
paroxysmal
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes