ACT DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation (TRAC-AF)

February 11, 2025 updated by: Medtronic Cardiac Ablation Solutions

Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Title: Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation: TRAC-AF

Sponsor: Advanced Cardiac Therapeutics 2880 Lakeside Drive Suite 250 Santa Clara, CA 95054

Protocol No: DTAF-CZ01

Product: Cardiac Ablation Catheter and RF Generator/Pump System Investigational Device: DiamondTemp System (Inclusive of the DiamondTemp Ablation Catheter, DiamondTemp Catheter-to-RFG Cable, DiamondTemp GenConnect Cable, DiamondTemp RF Generator, DiamondTemp Irrigation Pump and DiamondTemp Irrigation Tubing)

PROTOCOL SUMMARY Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation: TRAC-AF

Study Objective:

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

Investigational Device:

The investigational device in this clinical study is the DiamondTemp System inclusive of

  • DiamondTemp Catheter (UPN: CZDT100S, CZDT100L)
  • DiamondTemp Catheter-to RFG Cable (UPN: CZDC100)
  • DiamondTemp GenConnect Cable (UPN: CZDTGC100)
  • DiamondTemp RF Generator (UPN:CZDTG100)
  • DiamondTemp Irrigation Pump (UPN: CZDP100)
  • DiamondTemp Irrigation Tubing Set (UPN: CZDTS100)

System Accessories:

  • Dispersive Indifferent Patch (DIP) electrodes
  • Power Cord
  • EGM Cable (not supplied)
  • St. Jude Maestro GenConnect (not supplied)

The investigational device can be used with commonly available EP Recording System, Cardiac Stimulator and the ST. Jude EnSite™ Velocity™ Cardiac Mapping System.

There are no control devices in this study.

Study Design/Planned Number of Subjects/Number of Centers This study is a prospective, single center, single arm study. A maximum of 75 subjects will be enrolled in the study to include a maximum of 5 roll-in subjects in one investigational center in the Czech Republic.

Primary Endpoints The primary endpoint events for this trial as follows are to assess the safety and performance effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic PAF.

  • Primary Safety Endpoint: 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.
  • Primary Effectiveness Endpoint: 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.

Secondary Endpoints

The following secondary endpoint will be evaluated to support the results of the primary endpoints:

• Secondary Safety Endpoint: The chronic safety of the DiamondTemp System will be assessed by evaluating the nature and frequency of adverse events (AE) and adverse device effects (ADE) at 30 days, 90 days, 6 months and 12 months post-procedure.

Study Duration The duration of the study is expected to last approximately 18 months from the first enrollment to final report for assessment of endpoints. An additional 12 months to the study closeout after the last follow-up.

Key Inclusion Criteria

  • Suitable candidate for intra-cardiac mapping 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 atrial fibrillation (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

Key Exclusion Criteria

  • Previous ablation procedure in the left atrium
  • Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
  • Known severe cerebrovascular disease or history of cerebrovascular event (within 1 month)
  • 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
  • Uncontrolled congestive heart failure (NYHA Class III or IV)
  • Unstable angina or acute myocardial infarction within the past three months
  • Bleeding, clotting disorders, or known thrombosis
  • Heart valve replacement
  • Mitral clip (Evalve)
  • Unable or unwilling to take anti-coagulants

Ablation Procedure The ablation procedure will consist of documentation of pre-ablation pulmonary vein (PV) potentials, conducting PV isolation using the DiamondTemp System, providing documentation of PV entrance block. Investigator can opt to perform other ablations if any non- PV foci are involved in atrial arrhythmia.

Follow-up Schedule

  • Screening visit any time during six (6) months before ablation procedure
  • Ablation Procedure (Day 0, all follow-ups post ablation are based on this date)
  • Discharge (5-72 hours)
  • 7-Day Phone Check (7 + 3 days)
  • 1-Month Follow-up (30 + 5 days)
  • Repeat Mapping Procedure
  • Repeat Ablation Procedure, if necessary
  • 3-Month Follow-up (90 + 10 days)
  • 6-Month Follow-up (180 + 30 days)
  • 12-Month Follow-up (365 + 30 days)
  • Additional Follow-up visits (as determined necessary)

The study will be considered complete for the purpose of reporting results with regards to the primary endpoints after all subjects have completed the 7-Day follow-up. A final study closeout report will be created after the last 12-month follow-up visit.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • St Anne's University Hospital
      • Prague, Czechia
        • Nemocnice na Homolce
      • Praha, Czechia
        • Institut klinicke a experimentalni mediciny (IKEM)
  • France
      • Toulouse, France
        • Clinique Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Study Inclusion Criteria

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.

Study Exclusion Criteria

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)
  • Unstable angina or acute myocardial infarction within the past three months
  • Bleeding, clotting disorders, or known thrombosis
  • Severe Peripheral vascular disease
  • Uncontrolled diabetes
  • Rheumatic heart disease
  • Heart valve replacement
  • Mitral clip (Evalve)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DiamondTemp
Bilateral pulmonary vein isolation by RF ablation using DiamondTemp temperature controlled catheter and RF generator/pump system
Device: Radio frequency (RF) Cardiac ablation
Catheter based RF cardiac ablation to treat Paroxysmal Atrial Fibrillation
Other Names:
  • RF Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE)
Time Frame: Seven days
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
Time Frame: Seven days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) up to a year after treatment
Time Frame: During 12 months after the treatment
The chronic safety of the DiamondTemp System will be assessed by evaluating the nature and frequency of adverse events (AE) and adverse device effects (ADE) at 30 days, 90 days, 6 months and 12 months post-procedure
During 12 months after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Principal Investigator: Petr Neuzil, MD, PhD, Na Homolce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimated)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTAF-CZ01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paroxysmal Atrial Fibrillation

Clinical Trials on Radio frequency (RF) Cardiac ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe