Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures

NCT02768051 | Withdrawn

• 1 other identifier: CLN-D700-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter. Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• Safety Endpoint - Any intra-procedural or immediate post-procedure complications.

  Intra-procedural or immediate post-procedure

Secondary Outcomes (2)

• Feasibility - Freedom from any impact on current workflow or clinical efficacy.

  Intra-procedural or immediate post-procedure

• Usability - Correct visualization of the catheter spatial location (map reference).

  Intra-procedural or immediate post-procedure

Study Arms (1)

AF Ablation Intervention

EXPERIMENTAL

Subjects who are scheduled to undergo ablation procedure due to atrial flutter.

Procedure: AF Ablation

Interventions

AF Ablation PROCEDURE

AF Ablation Intervention

Eligibility Criteria

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

You may qualify if:

• Subject is at least 18 years of age.
• Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
• Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
• Subject is generally in good health.
• A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
• Subject is deemed amenable to therapeutic ablation for atrial flutter.

You may not qualify if:

• Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
• Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
• Patient had experienced previous stroke (TIA or CVA).
• Patient has a pacemaker.
• Thrombi detected in the heart.
• Known marked valvar insufficiency.
• Life expectancy less than 12 months.
• Known severe renal insufficiency.

Sponsors & Collaborators

• EPD Solutions, A Philips Company: lead

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

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

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: May 1, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 17, 2018

Record last verified: 2018-05