Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation

NCT03140631 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00117851
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.

Conditions

Atrial Fibrillation; Catheter Ablation

Keywords

atrial fibrillation; catheter ablation; protamine sulfate; anticoagulation reversal

Outcome Measures

Primary Outcomes (1)

• Time to Ambulation

  Total length of time from procedural termination to patient ambulation

  0 to 24 hours

Secondary Outcomes (1)

• Count of Participants Who Experienced Vascular Access Site Complications

  checked at 30 and 90 days

Study Arms (2)

Control

NO INTERVENTION

Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of \<200s or return to pre-procedural baseline prior to sheath removal.

Protamine

ACTIVE COMPARATOR

Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs.ACT levels will then be monitored with a goal ACT of \<200s or return to preprocedural baseline prior to removal of vascular sheaths.

Drug: Protamine Sulfate

Interventions

Protamine Sulfate DRUG

Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.

Protamine

Eligibility Criteria

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

You may qualify if:

• Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).
• Age ≥ 18 year
• Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.

You may not qualify if:

• Previous intolerance or allergy to heparin products.
• Current or prior administration of protamine products
• History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.
• Known lower extremity venous thrombosis.
• Coagulopathy or blood dyscrasias.
• Active malignancy.
• Thrombocytosis (platelet count \>600k/ul) or thrombocytopenia (platelet count \<100k/ul)
• Planned use of vascular closure device

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Protamines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nuclear Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nucleoproteins

Results Point of Contact

• Title: Dr. Hakan Oral
• Organization: Michigan Medicine

oralh@med.umich.edu

734-936-8214

Study Officials

• Hakan Oral, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Arrhythmia Service

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: May 4, 2017
• Study Start: March 23, 2017
• Primary Completion: November 16, 2017
• Study Completion: April 3, 2018
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)