Clinical trial NCT03643224: DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
Official title: A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Atrial Fibrillation
Keywords: ablation
electrophysiology
atrial fibrillation
catheter
persistent
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of device or procedure related Serious Adverse Events measured at 7 days in all subjects
timeFrame: 7 days after the index ablation procedure
measure: Incidence of device or procedure related clinically significant tamponade/perforation measured at 30 days in all subjects.
timeFrame: 30 days after the index ablation procedure
measure: Incidence of symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months in all subjects.
timeFrame: 6 months after the index ablation procedure
measure: Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes for all subjects.
timeFrame: 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).
Secondary outcomes:
measure: Incidence of device or procedure related Serious Adverse Events measured at 30 days in all subjects.
timeFrame: 30 days after the index ablation procedure
measure: 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.
timeFrame: 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).
measure: Incidence of asymptomatic pericardial effusion of 1cm or more in size
timeFrame: 30 days after the index ablation procedure
measure: Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting ≥30 seconds in duration by ECG or ECG monitoring system
timeFrame: 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).
measure: Rate of acute procedural success
timeFrame: Day of index ablation procedure
measure: Rate of single procedure success
timeFrame: 12 months after the index ablation procedure
measure: Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period
timeFrame: Day of index ablation procedure
measure: Accumulated changes in Quality of Life (QOL) using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire
timeFrame: Between 6 months and 12 months after the index ablation procedure
measure: Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Between baseline and 12 months after the index ablation procedure
measure: Total procedure time (minutes)
timeFrame: Immediately after the index ablation procedure
measure: Total time to achieve initial PVI (minutes)
timeFrame: Day of index ablation procedure
measure: Ability to perform first-pass PV antral isolation
timeFrame: Day of index ablation procedure
measure: Total treatment device time (minutes)
timeFrame: Day of index ablation procedure
measure: Mean cumulative RF Time (minutes).
timeFrame: Day of index ablation procedure
measure: Mean duration of RF ablations (seconds)
timeFrame: Day of index ablation procedure
measure: Total fluid infused through the investigational catheter (mL)
timeFrame: Day of index ablation procedure
measure: Total fluoroscopy time (minutes)
timeFrame: Day of index ablation procedure
measure: Incidence of re-hospitalizations due to atrial fibrillation recurrence.
timeFrame: 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).
measure: Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation
timeFrame: 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).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University Of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Keck School Of Medicine
state: California
city: Orlando
country: United States
facility: Advent Health, Florida Hospital Orlando
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
state: Quebec
city: Praha
country: Czechia
facility: Na Homolce
state: Prague
city: Brno
country: Czechia
facility: St Ann's University Hospital
city: Praha
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny (IKEM)
city: Villeurbanne
country: France
facility: Clinique du Tonkin
state: Lyon
city: Nancy
country: France
facility: CHRU Nancy
city: Perpignan
country: France
facility: Clinique Saint Pierre
city: Toulouse
country: France
facility: Clinique Pasteur
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
state: Milano
city: Venezia
country: Italy
facility: Ospedale dell'Angelo
Study officials:
affiliation: Medical Director, Heart Rhythm Program, Southlake Regional Health Centre
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References: