Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

NCT03626649 | Completed

• 1 other identifier: TP00983
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Freedom from a composite of serious adverse events (SAE)

  Freedom from a composite of serious adverse events (SAE)

  30 days

• Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes

  Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes

  12 months

Secondary Outcomes (3)

• Freedom from a composite SAE

  7 days

• Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes

  12 months

• Rate of single procedure success

  12 months

Study Arms (1)

DiamondTemp Cardiac Ablation System

EXPERIMENTAL

Cardiac ablation procedure

Device: DiamondTemp Cardiac Ablation System

Interventions

DiamondTemp Cardiac Ablation System DEVICE

The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of: * DiamondTemp Ablation Catheter o Unidirectional and Bidirectional models * DiamondTemp Catheter-to RFG Cable * DiamondTemp GenConnect Cable * DiamondTemp FASTR Generator with Footswitch * DiamondTemp Irrigation Pump * DiamondTemp Irrigation Tubing Set

Also known as: Cardiac ablation

DiamondTemp Cardiac Ablation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (4)

Na Homolce

Prague, 15000, Czechia

Location

Clnique du Tonkin

Lyon, France

Location

CHRU de Nancy

Nancy, France

Location

Clinique Pasteur

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 35581464 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Petr Neuzil, MD, PhD

  Na Homolce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: May 29, 2018
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); FR (3)