Typical Atrial Flutter, Ablation Index and Point by Point Ablation

NCT03867266 | Unknown DMC FDA Device

• 1 other identifier: 73/2018
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The Ablation of the typical atrial flutter can be considered substantially anatomical, the investigators want to test a protocol that foresees the use a lesion index (AI) and that respects the Inter-Lesion Distance (ILD) ≤ 6 mm on the cavo-tricuspid isthmus (CTI) The investigators want to prove how the introduction of a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency (RF) times

Conditions

Typical Atrial Flutter

Keywords

Ablation index; Interlesion distance

Outcome Measures

Primary Outcomes (1)

• First pass block of the cavo tricuspid isthmus

  Validation of the bidirectional block by pacing on the coronary sinus after completing the first line of the ablation

  9 months

Secondary Outcomes (3)

• radiofrequency time of application

  9 months

• Near zero x ray

  9 months

• Procedural time

  9 months

Interventions

Ablation with radiofrequency PROCEDURE

Ablation point by point on the cavo tricuspid isthmus guided by an index lesion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caucasian population regardless gender

You may qualify if:

• paroxysmal, persistent and /or long standing atrial flutter even in the presence of structural heart disease
• Informed consent form
• Age equal or above 18 years
• Skilled and willing to comply with all tests and follow up requirements
• Patients that ,in the context of ablation for fibrillation atrial, should also undergo to typical flutter ablation: in this case the data collected will be those related to typical flutter ablation.

You may not qualify if:

• Previous ablation for atrial flutter
• Atrial flutter secondary to electrolyte imbalance, thyroid disease or to a reversible or non-cardiac cause
• severe anemia,
• sepsis in progress
• Bypass procedure with coronary arterial artery in the last three months
• Pending cardiac transplantation or other cardiac surgery
• Pregnant or breastfeeding women
• Acute disease or active systemic infection or sepsis
• Documented left atrial thrombus
• Unstable angina
• Uncontrolled heart failure
• Life expectancy of less than 12 months
• Registration in any other study evaluating another device or medication
• Presence of intramural thrombi, tumor or other anomalies that preclude the introduction of the catheter into the vein system

Sponsors & Collaborators

• Ospedale San Francesco: lead

Study Sites (1)

Ospedale San Francesco

Nuoro, 08100, Italy

RECRUITING

Central Study Contacts

Graziana Viola, Medicine

CONTACT

+393401403816; grazianaviola@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: March 7, 2019
• Study Start: February 20, 2019
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

IT (1)