ACT DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation

NCT02821351 | Completed

• 1 other identifier: DTAF-CZ01
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 4

Brief Summary

The primary objective of this study is to establish the safety and performance effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF).

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Afib

Outcome Measures

Primary Outcomes (2)

• Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE)

  The safety of the DiamondTemp System will be assessed by evaluating the nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) during the time of the ablation procedure and within 7 days afterwards.

  Seven days

• Electrical Isolation of treated Pulmonary Vein from Left Atrium

  The effectiveness of the DiamondTemp System will be evaluated post-ablation with demonstration of acute procedural success defined as isolation of clinically relevant pulmonary veins by demonstration of block or isolation of signals confirmed after delivery of the ablation treatment. Depending on EP lab protocol, one method will be chosen.

  Seven days

Secondary Outcomes (1)

• Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) up to a year after treatment

  During 12 months after the treatment

Study Arms (1)

DiamondTemp

EXPERIMENTAL

Bilateral pulmonary vein isolation by RF ablation using DiamondTemp temperature controlled catheter and RF generator/pump system

Device: Radio frequency (RF) Cardiac ablation

Interventions

Radio frequency (RF) Cardiac ablation DEVICE

Catheter based RF cardiac ablation to treat Paroxysmal Atrial Fibrillation

Also known as: RF Ablation

DiamondTemp

Eligibility Criteria

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

You may qualify if:

• Subjects for this study must meet ALL of the following criteria:
• Suitable candidate for intra-cardiac mapping and ablation for arrhythmias.
• History of recurrent symptomatic PAF1 WITH ≥2 episodes reported within the 365 days (12) months prior to enrollment.
• At least one 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
• Competent and willing to provide written informed consent to participate in the study and agree to comply with the follow-up visits and evaluation.

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions apply:
• 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 (within 1 month)
• Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. This is calculated as follows for males:
• GFR = (140 - age) x weight x .85 (for females) PCr x 72 where age is specified in years, weight in kg, and PCr is Serum Creatinine in mg/dL Female GFR is reduced by 15% of the above calculated value for males.
• Active gastrointestinal bleeding
• Active infection or fever (\> 100.5 F/38 C)
• Sepsis
• Cardiac surgery within the past two months
• Short life expectancy (\< 1yr) 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 press. \> 240 mm Hg within the last 30 days)
• Documented anaphylaxis during previous exposure to angiographic contrast media
• Uncontrolled congestive heart failure (NYHA Class III or IV)

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (4)

St Anne's University Hospital

Brno, Czechia

Location

Institut Klinické a Experimentální Medicíny (IKEM)

Prague, Czechia

Location

Nemocnice Na Homolce

Prague, Czechia

Location

Clinique Pasteur

Toulouse, France

Location

Related Publications (2)

• Starek Z, Lehar F, Jez J, Pesl M, Neuzil P, Sediva L, Petru J, Dujka L, Funasako M, Kautzner J, Peichl P, Aldhoon B, Albenque JP, Combes S, Boveda S, Dukkipati SR, Reddy VY. Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study. J Interv Card Electrophysiol. 2022 Aug;64(2):375-381. doi: 10.1007/s10840-021-00986-0. Epub 2021 Jun 5.

  PMID: 34089431 DERIVED

• 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.

  PMID: 28750697 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 Hospital

  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

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 1, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2018
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CZ (3); FR (1)