DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— Diamond-AFII  

Official title:

A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03643224
• Other study ID #: TP01071
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: December 29, 2024

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 376
• Est. completion date: December 29, 2024
• Est. primary completion date: October 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Radiofrequency Ablation
A procedure will be performed using a radiofrequency ablation catheter.

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Regional Health Center	Newmarket	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Québec	Quebec
Czechia	St Ann's University Hospital	Brno
Czechia	Institut Klinicke a Experimentalni Mediciny (IKEM)	Praha
Czechia	Na Homolce	Praha	Prague
France	CHRU Nancy	Nancy
France	Clinique Saint Pierre	Perpignan
France	Clinique Pasteur	Toulouse	Cedex 3
France	Clinique du Tonkin	Villeurbanne	Lyon
Germany	Leipzig Heart Institute GmbH	Leipzig
Italy	Centro Cardiologico Monzino	Milan	Milano
Italy	Ospedale dell'Angelo	Venezia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Grandview Medical Center	Birmingham	Alabama
United States	University Of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Trident Medical Center	Charleston	South Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Keck School Of Medicine	Los Angeles	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Montefiore Medical Center	New York	New York
United States	Advent Health, Florida Hospital Orlando	Orlando	Florida
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of device or procedure related Serious Adverse Events measured at 7 days in all subjects	Freedom from a composite of pre-specified Serious Adverse Events	7 days after the index ablation procedure
Primary	Incidence of device or procedure related clinically significant tamponade/perforation measured at 30 days in all subjects.	Freedom from clinically significant tamponade/perforation occurring through 30 days.	30 days after the index ablation procedure
Primary	Incidence of symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months in all subjects.	Freedom from symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months	6 months after the index ablation procedure
Primary	Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes for all subjects.	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.	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	Incidence of device or procedure related Serious Adverse Events measured at 30 days in all subjects.	Freedom from a composite of pre-specified Serious Adverse Events	30 days after the index ablation procedure
Secondary	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.	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.	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	Incidence of asymptomatic pericardial effusion of 1cm or more in size	Rate of asymptomatic pericardial effusion of 1cm or more in size as documented by echocardiography up to 30 days following the index procedure	30 days after the index ablation procedure
Secondary	Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting =30 seconds in duration by ECG or ECG monitoring system	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	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	Rate of acute procedural success	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	Day of index ablation procedure
Secondary	Rate of single procedure success	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.	12 months after the index ablation procedure
Secondary	Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period	Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.	Day of index ablation procedure
Secondary	Accumulated changes in Quality of Life (QOL) using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire	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".	Between 6 months and 12 months after the index ablation procedure
Secondary	Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS)	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	Between baseline and 12 months after the index ablation procedure
Secondary	Total procedure time (minutes)	Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed.	Immediately after the index ablation procedure
Secondary	Total time to achieve initial PVI (minutes)	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.	Day of index ablation procedure
Secondary	Ability to perform first-pass PV antral isolation	Ability to perform first-pass PV antral isolation	Day of index ablation procedure
Secondary	Total treatment device time (minutes)	Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter.	Day of index ablation procedure
Secondary	Mean cumulative RF Time (minutes).	Mean cumulative RF Time (minutes).	Day of index ablation procedure
Secondary	Mean duration of RF ablations (seconds)	Mean duration of RF ablations (seconds)	Day of index ablation procedure
Secondary	Total fluid infused through the investigational catheter (mL)	Total fluid infused through the investigational catheter (mL)	Day of index ablation procedure
Secondary	Total fluoroscopy time (minutes)	Total fluoroscopy time (minutes)	Day of index ablation procedure
Secondary	Incidence of re-hospitalizations due to atrial fibrillation recurrence.	Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period.	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	Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation	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	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).