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Trial record 4 of 4 for:    DiamondTemp

DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation (Diamond-AFII)

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ClinicalTrials.gov Identifier: NCT03643224
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
EPIX Therapeutics

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

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Atrial Fibrillation Device: Radiofrequency Ablation Not Applicable

Detailed Description:
The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter
Device: Radiofrequency Ablation
A procedure will be performed using a radiofrequency ablation catheter.




Primary Outcome Measures :
  1. Incidence of device or procedure related Serious Adverse Events measured at 7 days in all subjects [ Time Frame: 7 days after the index ablation procedure ]
    Freedom from a composite of pre-specified Serious Adverse Events

  2. Incidence of device or procedure related clinically significant tamponade/perforation measured at 30 days in all subjects. [ Time Frame: 30 days after the index ablation procedure ]
    Freedom from clinically significant tamponade/perforation occurring through 30 days.

  3. Incidence of symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months in all subjects. [ Time Frame: 6 months after the index ablation procedure ]
    Freedom from symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months

  4. Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes for all subjects. [ Time Frame: Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). ]
    Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter* (AFL) and atrial tachycardia (AT) episodes following the blanking period through the end of the effectiveness evaluation period.


Secondary Outcome Measures :
  1. Incidence of device or procedure related Serious Adverse Events measured at 30 days in all subjects. [ Time Frame: 30 days after the index ablation procedure ]
    Freedom from a composite of pre-specified Serious Adverse Events

  2. Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes in the absence of class I and II anti-arrhythmic drug therapy for all subjects. [ Time Frame: Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). ]
    Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.

  3. Incidence of asymptomatic pericardial effusion of 1cm or more in size [ Time Frame: 30 days after the index ablation procedure ]
    Rate of asymptomatic pericardial effusion of 1cm or more in size as documented by echocardiography up to 30 days following the index procedure

  4. Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting ≥30 seconds in duration by ECG or ECG monitoring system [ Time Frame: Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). ]
    Freedom from documented asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting ≥30 seconds in duration by ECG or ECG monitoring system

  5. Rate of acute procedural success [ Time Frame: Day of index ablation procedure ]
    Rate of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV

  6. Rate of single procedure success [ Time Frame: 12 months after the index ablation procedure ]
    Rate of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL* at 12 months.

  7. Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period [ Time Frame: Day of index ablation procedure ]
    Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.

  8. Accumulated changes in Quality of Life (QOL) using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire [ Time Frame: Between 6 months and 12 months after the index ablation procedure ]

    Accumulated changes in QOL using the AFEQT Questionnaire from baseline through 6 and 12 months following ablation procedure.

    Section 1 measures occurrence of atrial fibrillation by asking the subject if they are in atrial fibrillation. If they answer "No", it asks for the last time they had atrial fibrillation ranging from the subject were never aware of having atrial fibrillation (minimum) to more than 1 year ago (maximum).

    Section 2 measures how atrial fibrillation affects the subject's quality of life by asking a series of 20 questions that the subject rates on a scale of 1 to 7, how much was the subject bothered by their atrial fibrillation, one being "Not at all bothered" and 7 being "Extremely bothered".


  9. Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Between baseline and 12 months after the index ablation procedure ]

    The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.

    1a. Level of Consciousness (LOC) 0 - 3

    1b. LOC Questions 0 - 2

    1c. LOC Commands 0 - 2 2. Best Gaze 0 - 2 3. Visual 0 - 3 4. Facial Palsy 0 - 3 5. Motor Arm. 0 - 4 or UN = Amputation or joint fusion. Scored for both left and right arms.

    6. Motor Leg. 0 - 4 or UN = Amputation or joint fusion. Scored for both left and right legs.

    7. Limb Ataxia. 0 - 2 or UN = Amputation or joint fusion 8. Sensory. 0 - 2 9. Best Language. 0 - 3 10. Dysarthria. 0 - 2 or UN = Intubated or other physical barrier. 11. Extinction and Inattention. 0 - 2


  10. Total procedure time (minutes) [ Time Frame: Immediately after the index ablation procedure ]
    Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed.

  11. Total time to achieve initial PVI (minutes) [ Time Frame: Day of index ablation procedure ]
    Time to achieve initial PVI at index procedure (minutes), defined as time of delivery of first RF ablation with the investigational catheter until confirmation of PVI via entrance block following a 20-minute waiting period.

  12. Ability to perform first-pass PV antral isolation [ Time Frame: Day of index ablation procedure ]
    Ability to perform first-pass PV antral isolation

  13. Total treatment device time (minutes) [ Time Frame: Day of index ablation procedure ]
    Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter.

  14. Mean cumulative RF Time (minutes). [ Time Frame: Day of index ablation procedure ]
    Mean cumulative RF Time (minutes).

  15. Mean duration of RF ablations (seconds) [ Time Frame: Day of index ablation procedure ]
    Mean duration of RF ablations (seconds)

  16. Total fluid infused through the investigational catheter (mL) [ Time Frame: Day of index ablation procedure ]
    Total fluid infused through the investigational catheter (mL)

  17. Total fluoroscopy time (minutes) [ Time Frame: Day of index ablation procedure ]
    Total fluoroscopy time (minutes)

  18. Incidence of re-hospitalizations due to atrial fibrillation recurrence. [ Time Frame: Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). ]
    • Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period.



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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:

  1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
  2. Subjects with a history of documented symptomatic, persistent atrial fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months and 2) a 24-hour Holter within 90 days of the ablation procedure showing continuous AF.
  3. Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
  4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
  5. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
  6. Subject is willing and able to provide written consent.

Exclusion Criteria:

At time of enrollment and/or prior to procedure:

  1. Continuous AF >12 months (long-standing persistent AF)
  2. Paroxysmal AF with longest episode <7 days
  3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
  4. Rheumatic heart disease
  5. Severe mitral regurgitation
  6. Hypertrophic cardiomyopathy
  7. LA diameter >5.5 cm
  8. Left ventricular ejection fraction (LVEF) <40%
  9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure
  10. Body Mass Index (BMI) >42 kg/m2.
  11. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
  12. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
  13. Coagulopathy, bleeding diathesis or suspected procoagulant state
  14. Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure
  15. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
  16. Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
  17. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
  18. Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
  19. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
  20. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
  21. Life expectancy <12 months based on medical history or the medical judgement of the investigator.

    Within 1 month of enrollment or just prior to procedure:

  22. Documented LA thrombus upon imaging
  23. Creatinine >2.5mg/dl or creatinine clearance <30mL/min

    Within 3 months of enrollment:

  24. Significant gastrointestinal (GI) bleed
  25. Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention

    Within 6 months of enrollment:

  26. Coronary artery bypass graft (CABG) procedure
  27. Implant procedure performed for ICD, CRT leads or pacemaker
  28. Documented stroke, CVA, TIA or suspected neurological event

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): NCT03643224


Contacts
Contact: Elizabeth De Spain, BS 4084777550 edespain@actmed.net
Contact: Patty Hevey phevey@actmed.net

Locations
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Rose Cheatham, RN    601-982-7850      
Principal Investigator: Judson Colley, MD         
France
Clinique Pasteur Recruiting
Toulouse, Cedex 3, France, 31076
Contact: Juliette Goutner, RN    (+336)1373-1838      
Principal Investigator: Jean Paul Albenque, MD         
Clinique du Tonkin Recruiting
Villeurbanne, Lyon, France, 69100
Contact: Rafik Stiti, RN    (+33) (0)4 37 48 48 05      
Principal Investigator: Herve Poty, MD         
Sub-Investigator: Durand Dubief         
Sponsors and Collaborators
EPIX Therapeutics
Investigators
Principal Investigator: Atul Verma, MD Medical Director, Heart Rhythm Program, Southlake Regional Health Centre
Principal Investigator: Andrea Natale, MD Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Responsible Party: EPIX Therapeutics
ClinicalTrials.gov Identifier: NCT03643224     History of Changes
Other Study ID Numbers: TP01071
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by EPIX Therapeutics:
ablation
electrophysiology
atrial fibrillation
catheter
persistent

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