Clinical trial NCT03626649: Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
Official title: A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

Detailed description: * The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
* In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
* History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
* (12) months prior to enrollment
* At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
* Refractory to at least one Class I-IV anti-arrhythmic drug (AAD)
* Eighteen (18) years of age or above

Exclusion Criteria:

* Previous left atrial ablation procedure
* Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
* Known severe cerebrovascular disease or history of cerebrovascular event (\< 1 month)
* Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding
* Active infection or fever (\>100.5 F/38 ◦C)
* Sepsis
* Cardiac surgery within the past two months.
* Short life expectancy (\<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia (hemoglobin \< 8.0 mg/dL)
* Severe uncontrolled systemic hypertension (systolic pressure \> 240 mm Hg within the last 30 days)
* Documented anaphylaxis during previous exposure to angiographic contrast media
* Uncontrolled congestive heart failure (NYHA1 Class III or IV)
* Unstable angina or acute myocardial infarction within the past three months
* Bleeding, clotting disorders, or known thrombosis
* Severe Peripheral vascular disease
* Uncontrolled diabetes
* Heart valve replacement
* Mitral clip (E-valve)
* Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
* Active participation in another investigational protocol currently or the last 30 days
* Unable or unwilling to take anti-coagulants
* Unwilling or unable to comply with any protocol or follow up requirements

Primary outcomes:
measure: Freedom from a composite of serious adverse events (SAE)
timeFrame: 30 days
measure: Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from a composite SAE
timeFrame: 7 days
measure: Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes
timeFrame: 12 months
measure: Rate of single procedure success
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce
city: Lyon
country: France
facility: Clnique du Tonkin
city: Nancy
country: France
facility: CHRU de Nancy
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Na Homolce
name: Petr Neuzil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18.