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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03643224

Collaborator

(none)

376

Enrollment

Locations

Arm

67.3

Anticipated Duration (Months)

13.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

376 participants

Allocation:

N/A

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 :

Sep 20, 2018

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Apr 28, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of device or procedure related Serious Adverse Events measured at 7 days in all subjects [7 days after the index ablation procedure]
Freedom from a composite of pre-specified Serious Adverse Events
Incidence of device or procedure related clinically significant tamponade/perforation measured at 30 days in all subjects. [30 days after the index ablation procedure]
Freedom from clinically significant tamponade/perforation occurring through 30 days.
Incidence of symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months in all subjects. [6 months after the index ablation procedure]
Freedom from symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months
Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes for all subjects. [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

Incidence of device or procedure related Serious Adverse Events measured at 30 days in all subjects. [30 days after the index ablation procedure]
Freedom from a composite of pre-specified Serious Adverse Events
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. [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.
Incidence of asymptomatic pericardial effusion of 1cm or more in size [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
Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting ≥30 seconds in duration by ECG or ECG monitoring system [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
Rate of acute procedural success [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
Rate of single procedure success [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.
Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period [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.
Accumulated changes in Quality of Life (QOL) using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire [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".
Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) [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
Total procedure time (minutes) [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.
Total time to achieve initial PVI (minutes) [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.
Ability to perform first-pass PV antral isolation [Day of index ablation procedure]
Ability to perform first-pass PV antral isolation
Total treatment device time (minutes) [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.
Mean cumulative RF Time (minutes). [Day of index ablation procedure]
Mean cumulative RF Time (minutes).
Mean duration of RF ablations (seconds) [Day of index ablation procedure]
Mean duration of RF ablations (seconds)
Total fluid infused through the investigational catheter (mL) [Day of index ablation procedure]
Total fluid infused through the investigational catheter (mL)
Total fluoroscopy time (minutes) [Day of index ablation procedure]
Total fluoroscopy time (minutes)
Incidence of re-hospitalizations due to atrial fibrillation recurrence. [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.
Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation [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 during effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
Subjects with a history of documented symptomatic, persistent atrial fibrillation with

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.

Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
Subject is willing and able to provide written consent.

Exclusion Criteria:

At time of enrollment and/or prior to procedure:

Continuous AF >12 months (long-standing persistent AF)
Paroxysmal AF with longest episode <7 days
AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
Rheumatic heart disease
Severe mitral regurgitation
Hypertrophic cardiomyopathy
LA diameter >5.5 cm
Left ventricular ejection fraction (LVEF) <40%
Currently NYHA Class III or IV or exhibits uncontrolled heart failure
Body Mass Index (BMI) >42 kg/m2.
LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
Coagulopathy, bleeding diathesis or suspected procoagulant state
Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure
Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
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.
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.
Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
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.
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:

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

Within 3 months of enrollment:

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

Within 6 months of enrollment:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grandview Medical Center	Birmingham	Alabama	United States	35242
2	University Of Alabama	Birmingham	Alabama	United States	35294
3	Keck School Of Medicine	Los Angeles	California	United States	90033
4	Advent Health, Florida Hospital Orlando	Orlando	Florida	United States	32751
5	Iowa Heart Center	West Des Moines	Iowa	United States	50266
6	Kansas City Heart Rhythm Institute	Overland Park	Kansas	United States	66211
7	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
8	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
9	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
10	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
11	Montefiore Medical Center	New York	New York	United States	10467
12	Trident Medical Center	Charleston	South Carolina	United States	29406
13	Medical University Of South Carolina	Charleston	South Carolina	United States	29425
14	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705
15	Houston Methodist Hospital	Houston	Texas	United States	77030
16	Southlake Regional Health Center	Newmarket	Ontario	Canada	L3Y2P6
17	Montreal Heart Institute	Montreal	Quebec	Canada	HITC8
18	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Québec	Quebec	Canada	G1V4G5
19	Na Homolce	Praha	Prague	Czechia	15000
20	St Ann's University Hospital	Brno		Czechia	65691
21	Institut Klinicke a Experimentalni Mediciny (IKEM)	Praha		Czechia	14021
22	Clinique Pasteur	Toulouse	Cedex 3	France	31076
23	Clinique du Tonkin	Villeurbanne	Lyon	France	69100
24	CHRU Nancy	Nancy		France	54511
25	Clinique Saint Pierre	Perpignan		France	66000
26	Leipzig Heart Institute GmbH	Leipzig		Germany	04289
27	Centro Cardiologico Monzino	Milan	Milano	Italy	20138
28	Ospedale dell'Angelo	Venezia		Italy	30174

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

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