Clinical trial NCT03334630: DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Official title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Atrial Fibrillation
Keywords: ablation
electrophysiology
atrial fibrillation
catheter
paroxysmal
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:

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 symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.
3. At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
4. Refractory to at least one Class I-IV AAD for treatment of PAF.
5. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
6. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
7. Subject is willing and able to provide written consent.

STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:

At time of enrollment and/or prior to procedure:

1. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
2. LA diameter \> 5.5 cm.
3. LVEF \< 35%.
4. Currently NYHA Class III or IV or exhibits uncontrolled heart failure.
5. BMI \> 40 kg/m2.
6. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.
7. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
8. Coagulopathy, bleeding diathesis or suspected procoagulant state
9. Sepsis, active systemic infection or fever (\>100.5°F / 38°C) within a week prior to the ablation procedure.
10. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
11. 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.
12. 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.
13. Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
14. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
15. 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.
16. 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:
17. Documented LA thrombus upon imaging.
18. Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min.

    Within 2 months of enrollment:
19. Regularly (uninterrupted) prescribed amiodarone.

    Within 3 months of enrollment:
20. Significant GI bleed.
21. MI, unstable angina, cardiac surgery or coronary intervention.

    Within 6 months of enrollment:
22. CABG procedure.
23. ICD, CRT leads or pacemaker implant procedure.
24. Documented stroke, CVA, TIA or suspected neurological event.

    Within 12 months of enrollment:
25. An episode of AF lasting \>7 days in duration.

Primary outcomes:
measure: Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
timeFrame: Within 30-days or 6-months after index ablation procedure
measure: Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).
timeFrame: 3-12M (3-12 months) after index ablation procedure
Secondary outcomes:
measure: Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)
timeFrame: Index ablation procedure
measure: Mean Cumulative RF Time Per Procedure (Minutes)
timeFrame: Index ablation procedure
measure: Freedom From a Composite of SAE Occurring Within 7-days
timeFrame: Within 7-days after the index ablation procedure
measure: Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).
timeFrame: 3-12 months after index ablation procedure
measure: Rate of Acute Procedural Success
timeFrame: Index ablation procedure
measure: Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.
timeFrame: Index ablation procedure through 12-months after index ablation procedure
measure: Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.
timeFrame: Index ablation procedure through 12-months after index ablation procedure
measure: Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)
timeFrame: Index ablation procedure
measure: Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire
timeFrame: Baseline, 6-months after index ablation and 12-months after index ablation
measure: Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Baseline, pre-discharge after index ablation and 12-months after index ablation procedure
measure: Total Procedure Time (Minutes)
timeFrame: Index ablation procedure
measure: Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)
timeFrame: Index ablation procedure
measure: Total Treatment Device Time (Minutes)
timeFrame: Index ablation procedure
measure: Total Number of RF Ablations Per Procedure
timeFrame: Index ablation procedure
measure: Total Fluid Infused Through the Ablation Catheter (mL)
timeFrame: Index ablation procedure
measure: Total Fluoroscopy Time (Minutes)
timeFrame: Index ablation procedure
measure: Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period
timeFrame: 3-12 months after index 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: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Jackson
country: United States
facility: Jackson Heart Clinic
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 Research Institute
state: Texas
city: Toronto
country: Canada
facility: Southlake Regional Medical Centre
state: Newmarket/Ontario
city: Praha
country: Czechia
facility: Na Homolce
state: Prague
city: Brno
country: Czechia
facility: St Anne's University Hospital
city: Praha
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny (IKEM)
city: Toulouse
country: France
facility: Clinique Pasteur
state: Cedex 3
city: Villeurbanne
country: France
facility: Clinique du Tonkin
state: Lyon
city: Nancy
country: France
facility: CHRU Nancy
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
state: Milano
city: Mestre
country: Italy
facility: Ospedale dell'Angelo di Mestre
state: Venezia
Study officials:
affiliation: Institut klinické a experimentální medicíny (IKEM)
name: Josef Kautzner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: William Maddox, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Tom McElderry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.
citation: Kautzner J, Albenque JP, Natale A, Maddox W, Cuoco F, Neuzil P, Poty H, Getman MK, Liu S, Starek Z, Dukkipati SR, Colley BJ 3rd, Al-Ahmad A, Sidney DS, McElderry HT. A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Mar;7(3):352-363. doi: 10.1016/j.jacep.2020.11.009. Epub 2021 Jan 27.