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A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

HBI-3000

Placebo

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring cardioversion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 to 80 years of age
Sustained AF of > 2 hours and < 72 hours duration
Eligible for cardioversion (electrical and pharmacologic)
On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country specific national or international guidelines for thromboembolic risk reduction related to AF

Exclusion Criteria:

Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably established at the time of dosing
Hemodynamic instability that may require emergency electrical cardioversion
Atrial flutter
Moderate to severe HF
Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity
Known or suspected hyperthyroidism
Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at rest within the previous 3 months
Presence of LA thrombus by TEE or TTE
Presence of concurrent myocarditis or endocarditis
ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or a complete bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with WPW syndrome; Acute coronary ischemia patterns
Use of medication that prolongs the QTc interval or history of: Long QT syndrome, congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular arrhythmia (not including infrequent isolated PVC)
Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong CYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives before enrollment)
Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration
Use of vernakalant, or any experimental drug within 30 days or five half-lives (whichever is longer) of Study Drug administration, or use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure
Clinically significant laboratory abnormalities

Sites / Locations

Grandview Medical Group Research
HonorHealth Research Institute and InnovationRecruiting
NCH Research InstituteRecruiting
Research Physicians Network Alliance/Florida Cardiology
Prairie Education & Research
St. Vincent Heart CenterRecruiting
Lutheran Hospital
UofL Health - UofL Physicians, Cardiology AssociatesRecruiting
North Mississippi Medical CenterRecruiting
AMG Heart and Vascular CenterRecruiting
Ascension St. John Clinical Research InstituteRecruiting
CHRISTUS Trinity Mother Frances Hospital - TylerRecruiting
Gold Coast University HospitalRecruiting
University Clinical Center of the Republic of SrpskaRecruiting
University Clinical Center TuzlaRecruiting
Montreal Heart InstituteRecruiting
Centre hospitalier de L'Universite de Montral (CHUM)Recruiting
Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le GardeurRecruiting
Seoul National University Bundang HospitalRecruiting
Chonnam National University HospitalRecruiting
Auckland City Hospital
Waikato Hospital
Wellington Regional HospitalRecruiting
University Clinical Center of SerbiaRecruiting
University Hospital Medical Center Bezanijska kosaRecruiting
Clinical Hospital Center ZvezdaraRecruiting
Health Center UziceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Drug: HBI-3000, Stage A Dose Level 1

Drug: HBI-3000, Stage A Dose Level 2

Drug: HBI-3000, Stage A Dose Level 3

Drug: HBI-3000, Stage B Dose Level 1

Drug: HBI-3000, Stage B Dose Level 2

Arm Description

Stage A Open Label HBI-3000 Dose Level 1: 200 mg

Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned

Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned

Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results

Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results

Outcomes

Primary Outcome Measures

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR)

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in heart rate (HR) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: HR < 40 bpm for 2 minutes or longer within 90 minutes of initiation of the infusion HR increase > 25 percent before conversion to SR (based on one minute averages compared between the event and the first minute of stable telemetry) HR > 120 bpm for one minute or longer after conversion to SR and within 90 minutes of initiation of the infusion

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP)

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in blood pressure (BP) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: Systolic BP < 90 mmHg for > 1 minute during SR and within 90 minutes of initiation of the infusion

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes from baseline (prior to Study Drug infusion) to 24 hour post-infusion, specifically: QTcF: > 500 msec and > 60 msec above the 24-hour post-conversion level during SR PR: > 50 percent above the 24-hour post-conversion level during SR QRS: ≥ 33 percent above the 24-hour post-conversion level during SR

The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR

Evaluate the efficacy of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset as measured by the proportion of patients with AF of recent onset who convert to SR (for a duration of at least one minute) within 120 minutes of the start of infusion

Secondary Outcome Measures

Evaluate the time to conversion to SR from start of infusion

Efficacy as measured by the time from the start of infusion to the time of conversion to SR for a duration of at least one minute

Evaluate the proportion of patients with sustained AF or late conversion to SR

Efficacy as measured by the proportion of patients with sustained or late conversion of AF of recent onset to SR at 12 hours, 24 hours and 7 days after start of infusion

Full Information

NCT ID

NCT04680026

First Posted

December 17, 2020

Last Updated

September 28, 2023

Sponsor

HUYABIO International, LLC.

1. Study Identification

Unique Protocol Identification Number

NCT04680026

Brief Title

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

Official Title

A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI 3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HUYABIO International, LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF). Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group. Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be powered to show a difference between HBI-3000 and placebo in conversion rate at each of the two dose levels.

Detailed Description

This is a two-stage study in patients with AF of recent onset: Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). For each dosing cohort, sentinel dosing is planned. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment. In Stage A, three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group. The actual dose levels may be modified, and additional dose levels may be considered based on the observed results at each cohort. Stage B is the randomized, double-blind and placebo-controlled part of the study. Study drug for Stage B patients is either HBI-3000 or placebo. Two cohorts will be enrolled sequentially, lowest dose level first, with safety, efficacy, and available PK results evaluated by the Sponsor and iDMC prior to enrolling patients in the next/higher dose cohort. The dose level for the second cohort may be adjusted following interim review of results in the first cohort. Patients will be randomized to receive a single IV infusion of HBI 3000 or placebo over 30 minutes. In each of the dose cohorts, sequentially enrolled patients will be randomized at 2:1 ratio so that 40 patients will receive HBI 3000 infusion and 20 patients will receive placebo infusion. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

cardioversion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Allocation: Stage A: non-randomized; Stage B: randomized, double-blind and placebo-controlled Intervention Model: Two-stage study Masking: None; Stage A (open label); Stage B: randomized, double-blind and placebo-controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug: HBI-3000, Stage A Dose Level 1

Arm Type

Experimental

Arm Description

Stage A Open Label HBI-3000 Dose Level 1: 200 mg

Arm Title

Drug: HBI-3000, Stage A Dose Level 2

Arm Type

Experimental

Arm Description

Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned

Arm Title

Drug: HBI-3000, Stage A Dose Level 3

Arm Type

Experimental

Arm Description

Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned

Arm Title

Drug: HBI-3000, Stage B Dose Level 1

Arm Type

Experimental

Arm Description

Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results

Arm Title

Drug: HBI-3000, Stage B Dose Level 2

Arm Type

Experimental

Arm Description

Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results

Intervention Type

Drug

Intervention Name(s)

HBI-3000

Other Intervention Name(s)

sulcardine sulfate

Intervention Description

Small molecule, multi-ion channel blocker

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline

Primary Outcome Measure Information:

Title

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)

Description

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)

Time Frame

30 days

Title

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR)

Description

Time Frame

90 minutes

Title

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP)

Description

Time Frame

90 minutes

Title

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level

Description

Time Frame

24 hours

Title

The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR

Description

Time Frame

120 minutes

Secondary Outcome Measure Information:

Title

Evaluate the time to conversion to SR from start of infusion

Description

Efficacy as measured by the time from the start of infusion to the time of conversion to SR for a duration of at least one minute

Time Frame

24 hours

Title

Evaluate the proportion of patients with sustained AF or late conversion to SR

Description

Efficacy as measured by the proportion of patients with sustained or late conversion of AF of recent onset to SR at 12 hours, 24 hours and 7 days after start of infusion

Time Frame

12 hours, 24 hours and 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 to 80 years of age Sustained AF of > 2 hours and < 72 hours duration Eligible for cardioversion (electrical and pharmacologic) On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country specific national or international guidelines for thromboembolic risk reduction related to AF Exclusion Criteria: Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably established at the time of dosing Hemodynamic instability that may require emergency electrical cardioversion Atrial flutter Moderate to severe HF Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity Known or suspected hyperthyroidism Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at rest within the previous 3 months Presence of LA thrombus by TEE or TTE Presence of concurrent myocarditis or endocarditis ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or a complete bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with WPW syndrome; Acute coronary ischemia patterns Use of medication that prolongs the QTc interval or history of: Long QT syndrome, congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular arrhythmia (not including infrequent isolated PVC) Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong CYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives before enrollment) Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration Use of vernakalant, or any experimental drug within 30 days or five half-lives (whichever is longer) of Study Drug administration, or use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure Clinically significant laboratory abnormalities

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jerry Riebman, MD, FACS, FACC

Phone

858-798-8800

jriebman@huyabio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne Romano, PhD

Phone

858-798-8800

sromano@huyabio.com

Facility Information:

Facility Name

Grandview Medical Group Research

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

Country

United States

Individual Site Status

Withdrawn

Facility Name

HonorHealth Research Institute and Innovation

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sue DerbyShire

Phone

480-323-1046

SDerbyShire@honorhealth.com

First Name & Middle Initial & Last Name & Degree

Rahul Doshi, MD

Facility Name

NCH Research Institute

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathy Byrd

Phone

239-624-8113

kathy.byrd@nchmd.org

First Name & Middle Initial & Last Name & Degree

Dinesh Sharma, MD

Facility Name

Research Physicians Network Alliance/Florida Cardiology

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32792

Country

United States

Individual Site Status

Withdrawn

Facility Name

Prairie Education & Research

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62701

Country

United States

Individual Site Status

Terminated

Facility Name

St. Vincent Heart Center

City

Carmel

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelly Verel

Phone

317-388-8042

kelly.verel@ascension.org

First Name & Middle Initial & Last Name & Degree

Parin Patel, MD

Facility Name

Lutheran Hospital

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Individual Site Status

Withdrawn

Facility Name

UofL Health - UofL Physicians, Cardiology Associates

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Copeland

Phone

502-540-3409

stephanie.copeland@uoflhealth.org

First Name & Middle Initial & Last Name & Degree

Naresh Solankhi, MD

Facility Name

North Mississippi Medical Center

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yvonne Ray

Phone

662-377-5447

yray@nmhs.net

First Name & Middle Initial & Last Name & Degree

James E Stone, Jr, MD

Facility Name

AMG Heart and Vascular Center

City

Bartlesville

State/Province

Oklahoma

ZIP/Postal Code

74006

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anderson Mehrle, MD

First Name & Middle Initial & Last Name & Degree

Anderson Mehrle, MD

Facility Name

Ascension St. John Clinical Research Institute

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74101

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicholas Hanna, MD

Phone

918-744-3426

nicholas.hanna@ascension.org

First Name & Middle Initial & Last Name & Degree

Nicholas Hanna, MD

Facility Name

CHRISTUS Trinity Mother Frances Hospital - Tyler

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jamie Wylie

Phone

903-606-3737

jamiecrystal.wylie@christushealth.org

First Name & Middle Initial & Last Name & Degree

Stanislav Weiner, MD

Facility Name

Gold Coast University Hospital

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Satyajit R Jayasinghe, MD

First Name & Middle Initial & Last Name & Degree

Satyajit R Jayasinghe, MD

Facility Name

University Clinical Center of the Republic of Srpska

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamara Kovacevic-Preradovic, MD, PhD

Phone

+387 66 941391

tamara.kovacevic@medicolaser.info

First Name & Middle Initial & Last Name & Degree

Tamara Kovacevic-Preradovic, MD, PhD

Facility Name

University Clinical Center Tuzla

City

Tuzla

ZIP/Postal Code

75000

Country

Bosnia and Herzegovina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elnur Smajic, MD

Phone

+387 61 185437

elnurs@gmail.com

First Name & Middle Initial & Last Name & Degree

Elnur Smajic, MD

Facility Name

Montreal Heart Institute

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denis Roy, MD

Facility Name

Centre hospitalier de L'Universite de Montral (CHUM)

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit Coutu, MD

Facility Name

Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur

City

Terrebonne

State/Province

Quebec

ZIP/Postal Code

J6V 2H2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilbert Gosselin, MD

First Name & Middle Initial & Last Name & Degree

Gilbert Gosselin, MD

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Il-Young Oh, MD

First Name & Middle Initial & Last Name & Degree

Il-Young Oh, MD

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ki Hong Lee, MD

First Name & Middle Initial & Last Name & Degree

Ki Hong Lee, MD

Facility Name

Auckland City Hospital

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Individual Site Status

Withdrawn

Facility Name

Waikato Hospital

City

Hamilton

ZIP/Postal Code

3240

Country

New Zealand

Individual Site Status

Completed

Facility Name

Wellington Regional Hospital

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Nurse

Phone

04 918 5117

Facility Name

University Clinical Center of Serbia

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milika Asanin, MD

First Name & Middle Initial & Last Name & Degree

Mikka Asanin, MD

Facility Name

University Hospital Medical Center Bezanijska kosa

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marija Zdravkovic, MD

Phone

+381 64 8114258

sekcija.kardioloska@gmail.com

First Name & Middle Initial & Last Name & Degree

Marija Zdravkovic, MD

Facility Name

Clinical Hospital Center Zvezdara

City

Belgrade

ZIP/Postal Code

11120

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bojan Jasovic, MD

First Name & Middle Initial & Last Name & Degree

Bojan Jasovic, MD

Facility Name

Health Center Uzice

City

Užice

ZIP/Postal Code

31000

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadezda Trifunovic, MD

First Name & Middle Initial & Last Name & Degree

Nadezda Trifunovic, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

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